Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-09 @ 12:21 AM
Study NCT ID:
NCT02367105
Status:
COMPLETED
Last Update Posted:
2022-07-26
First Post:
2015-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lifestyle Intervention and Testosterone Replacement in Obese Seniors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007006', 'term': 'Hypogonadism'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}], 'ancestors': [{'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dennis.villareal@va.gov', 'phone': '713-794-7156', 'title': 'Dennis T Villareal, MD', 'organization': 'Michael E DeBakey VA Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 12, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 6, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'hypoglycemia, asymptomatic and symptomatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated PSA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness/orthostasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Idiopathic thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperosmolar hyperglycemic state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Physical Performance Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline values as covariate'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'The primary functional outcome is the modified physical performance test, which includes seven standardized tasks (walking 50 ft, putting on and removing a coat, picking up a penny, standing up from a chair, lifting a book, climbing one flight of stairs, and performing a progressive Romberg tests) plus two additional tasks (climbing up and down four flights of stairs and performing a 360-degree turn). The score for each task ranges form 0 to 4; a perfect score is 36. Higher scores indicate better physical function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Endurance Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline value adjusted'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Assessed by measuring peak oxygen consumption using indirect calorimetry during a treadmill exercise stress test', 'unitOfMeasure': 'ml/kg/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Functional Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.97', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.0', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline value adjusted'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Assessed by the Functional Status Questionnaire. Score range: 0 to 36 with higher scores indicating better functional status\n\nProvides information of the participants ability to perform activities of daily living.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.6', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-9.8', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.56', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline value adjusted'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Measured after an overnight fast using calibrated scales', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Lean Body Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Assessed by using dual-energy x-ray absorptiometry', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Fat Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-8.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.91', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Assessed by using dual-energy x-ray absorptiometry', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Thigh Muscle Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '-68', 'spread': '10', 'groupId': 'OG000'}, {'value': '-25', 'spread': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-42', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline value adjusted'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Assessed by using magnetic resonance imaging', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Thigh Fat Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '-292', 'spread': '31', 'groupId': 'OG000'}, {'value': '-262', 'spread': '32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.67', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline values as covariates'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Volume of fat in the thigh by measured by magnetic resonance imaging', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Hip Bone Mineral Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.013', 'spread': '0.002', 'groupId': 'OG000'}, {'value': '0.007', 'spread': '0.002', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.019', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline valued adjusted'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Assessed by using dual-energy x-ray absorptiometry', 'unitOfMeasure': 'gm/cm^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Lumbar Spine Bone Mineral Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '0.004', 'spread': '0.004', 'groupId': 'OG000'}, {'value': '0.007', 'spread': '0.004', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.003', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline value adjusted'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'As measured by Dual energy x-ray absorptiometry', 'unitOfMeasure': 'gm/cm^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Muscle Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'spread': '5', 'groupId': 'OG000'}, {'value': '68', 'spread': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.94', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline value adjusted'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'assessed by total1-repetition maximum (the maximal weight lifted at one time; the totals are the sum of the maximal weights lifted in the biceps curl, bench press, 387 seated row, knee extension, knee flexion, and leg press exercises).', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Static Balance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline value adjusted'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'assessed by one leg limb stance', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Dynamic Balance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}, {'id': 'OG001', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.46', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline values as covariates'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Assessed by using the obstacle course', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Gait Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.96', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Baseline value adjusted'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Determined by measuring the time needed to walk 25 ft.', 'unitOfMeasure': 'm/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Composite Cognitive Z-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '.273', 'spread': '.061', 'groupId': 'OG000'}, {'value': '.557', 'spread': '.065', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-.284', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Test of overall cognitive performance formed by averaging the standardized scores for several domains of cognitive function (attention, memory, executive, language, global). Higher scores indicate better cognitive status.\n\nThe Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of the baseline scores (units on a scale). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Modified Mini-mental Exam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.16', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline value and years of education as covariates'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Test of global cognition with components for orientation, registration, attention, language, praxis, and immediate and delayed memory. Score ranges from 0 to 100 with higher scores indicate better cognition.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stroop Interference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline values and years of education as covariates'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.\n\nMinimum score is 0, there is no maximum value. Higher scores indicate better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Word List Fluency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline values and years of education as covariates'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Measure of verbal production, semantic memory, and language. Minimum score is 0, there is no maximum value. Higher scores indicate better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Ray Auditory Verbal Learning Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-4.0', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline value and years if education as covariates'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'The Rey Auditory Verbal Learning Test (RAVLT) evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information.\n\nMinimum score is 0, there is no maximum value. Higher scores indicate better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Trail A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.7', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-13.9', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '6.6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline values and years of education as covariates'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Test of visuospatial scanning, speed of processing, mental flexibility, and executive function (with a greater focus on attention).\n\nMinimum score is 0, there is no maximum value. Higher scores indicate better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Trail B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.2', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '-19.5', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '7.8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline values and years of education as covariates'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Test of visuospatial scanning, speed of processing, mental flexibility, and executive function (with a focus on executive function)\n\nMinimum score is 0, there is no maximum value. Higher scores indicate better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Symbol Digital Modalities Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline values and years of education as covariates'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Assesses key neurocognitive functions that underlie many substitution tasks, including attention, visual scanning, and motor speed.\n\nMinimum score is 0, there is no maximum value. Higher scores indicate better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Trabecular Bone Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '.01', 'groupId': 'OG000'}, {'value': '.11', 'spread': '.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.65', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.01', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline values as covariates'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'The trabecular bone score is a measure of bone texture correlated with bone microarchitecture and a marker for the risk of osteoporosis.\n\nMinimum score is 0, there is no maximum value. Higher scores indicate better bone microarchitecture.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in C-terminal Telopeptide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '0.530', 'spread': '.012', 'groupId': 'OG000'}, {'value': '0.002', 'spread': '0.012', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.553', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline value adjusted'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'biochemical marker of bone turnover (bone resorption) as measured by immunoassay technique', 'unitOfMeasure': 'µg/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in N-terminal Propeptide of Type I Procollagen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.7', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-6.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline value adjusted'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Biochemical marker of bone turnover (bone formation) as measured by radioimmunoassay technique', 'unitOfMeasure': 'µg/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Insulin Growth Factor-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '16.9', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '5.5', 'pValueComment': 'Baseline value adjusted', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Measured by immunoassay methodology', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Trabecular Bone Score (Trabecular Bone Quality)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}, {'id': 'OG001', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}], 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'spread': '.01', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.01', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline value adjusted'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'assessed by trabecular bone score (TBS), a newly developed index for assessing trabecular bone quality and fracture risk.\n\nTBS is a bone texture parameter that quantifies cancellous bone microachitecture, which is key in determining bone strength and resistance to fracture, by computing raw data from dual energy x-ray absorptiometry of the lumbar spine.\n\nThere are no minimum or maximum values. Higher scores mean better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Levels of 25-hydroxyvitamin D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-2.4', 'pValueComment': 'Baseline value adjusted', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'assessed by using immunoassay methodology', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Parathyroid Hormone Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '12.9', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-3.6', 'pValueComment': 'Baseline value adjusted', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Measured by immunoassay methodology as marker of bone metabolism', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in High-sensitivity C-reactive Protein (Inflammatory Marker)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '.19', 'spread': '.05', 'groupId': 'OG000'}, {'value': '.18', 'spread': '.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.01', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'measured in the peripheral blood using immunoassay technique methodology', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Interleukin-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline value adjusted'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Measured from fasting serum using immunoassay technique as marker of inflammation', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Total Testosterone Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '21', 'groupId': 'OG000'}, {'value': '306', 'spread': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-252', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline value adjusted'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'as measured in the peripheral blood by liquid chromatography/mass spectrometry', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}, {'id': 'OG001', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '22.1', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-24.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline value as covariates'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'As measured by LC-MS/MS', 'unitOfMeasure': 'pg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-2.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline values as covariates'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'the ratio of the volume of red blood cells to the total volume of blood.', 'unitOfMeasure': 'percentage of red blood cells', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Prostate Specific Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.31', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline value adjusted'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'blood test to screen for prostate cancer', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Short Form Health Survey (SF-36) Quality of Life Physical Component', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.42', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.2', 'pValueComment': 'Baseline values as covariates', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Using Short Form-36 of Life Questionnaire Physical Component subscale. Minimum score is 0, Maximum score is 100. Higher scores indicate better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in International Prostate Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline value adjusted'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Using the International Prostate Symptom Scoring (IPS); Minimum score is 0, Maximum score is 35. Higher scores mean worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Triglyceride Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '-39', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '-31', 'spread': '5.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-13.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline value adjusted'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Blood samples obtained in the fasting state as part of measurements of lipid profile', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in HDL-cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '5.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Blood samples obtained in the fasting state as part of measurements of lipid profile', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-8.4', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.36', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.0', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline values as covariates'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Waist circumference as measured horizontally at the midpoint between the highest point of the iliac crest and the lowest portion of the 12th rib in the standing position.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.5', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '-17.1', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-8.6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline values as covariates'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Measured in the blood after overnight fast', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Mood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.43', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-1.39', 'spread': '0.39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.31', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline values adjusted'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Using Yesavage Depression Scale Lower scores indicate better mood (range 0 to 30).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Significant Changes in Functional Connectivity in the Default Mode Network', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'title': 'DMN (MPFC seed)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'DMN (PCC seed)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Number of participants', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0', 'pValueComment': 'A priori threshold = voxel p\\<.001, cluster p\\<.05, false discovery rate (FDR) whole brain correction. There is no correction for multiple seeds given small sample sizes and pre-post design.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 6 months', 'description': 'Functional connectivity was measured with seeds of the DMN (medial prefrontal cortex \\[MPFC\\] and posterior cingulate cortex \\[PCC\\]). Correlation coefficients representing the degree of connectivity between hypothesized regions were Fisher transformed. An a priori threshold of p\\<.001 at the voxel level and p\\<.05, FDR corrected for multiple comparisons across the whole brain, at the cluster level were used to determine significant connectivity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects per group is less than the overall number of subjects enrolled in the trial because this was an add-on outcome later in the study. Moreover, the analyses are limited to subjects with complete evaluable pre and post-MRI data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Skeletal Muscle Growth Factor (MYOD1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone Plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '0.23', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.23', 'pValueComment': "Using DESeq2 R package. P values were adjusted using the Benjamini and Hochberg's approach for controlling the false discovery rate.", 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05', 'groupDescription': '6 months vs Baseline', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.02', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.58', 'pValueComment': "Using DESeq2 R package. P values were adjusted using the Benjamini and Hochberg's approach for controlling the false discovery rate", 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': '6 months vs Baseline', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Assessed by using RNA-seq quantification of gene expression in skeletal muscles obtained during muscle biopsies.', 'unitOfMeasure': 'log2fold', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Peripheral Quantitative Computed Tomography Measures (Volumetric Bone Density)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'OG001', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.05', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Final vs baseline'}, {'pValue': '0.3', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Final vs baseline'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'assessed by quantitative computed tomography at 4% distal tibia using the following thresholds: 180 mg/cm3 and 45% of the area', 'unitOfMeasure': 'mg/cm^3', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'FG001', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Participants were recruited through advertisements and review of medical records at the Michael E DeBakey VA Medical Center.', 'preAssignmentDetails': 'After obtaining written informed consent, potential participants underwent a comprehensive medical screening procedure, including an exercise stress test. If they were found eligible based on the inclusion/exclusion criteria, they were randomized into one of the two treatment groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo + Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week\n\nPlacebo: Placebo gel for testosterone'}, {'id': 'BG001', 'title': 'Testosterone + Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training\n\nTestosterone: Daily testosterone gel applied once daily in the morning to intact skin\n\nLifestyle Therapy: Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.2', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '73.6', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '73.4', 'spread': '3.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Ethnicity was reported by the participants', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race was reported by the participants', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '36.9', 'spread': '4.9', 'groupId': 'BG000'}, {'value': '37.1', 'spread': '5.6', 'groupId': 'BG001'}, {'value': '37.0', 'spread': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The body-mass index is the weight in kilograms divided by the square of the height in meters', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total testosterone level', 'classes': [{'categories': [{'measurements': [{'value': '218', 'spread': '43', 'groupId': 'BG000'}, {'value': '210', 'spread': '63', 'groupId': 'BG001'}, {'value': '214', 'spread': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measured in the blood during early am in the fasting state.', 'unitOfMeasure': 'ng/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Physical Performance Test score', 'classes': [{'categories': [{'measurements': [{'value': '28.3', 'spread': '3.1', 'groupId': 'BG000'}, {'value': '28.5', 'spread': '2.8', 'groupId': 'BG001'}, {'value': '28.4', 'spread': '2.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The test includes walking 50 ft, putting on and removing a coat, picking up a penny, standing from a chair, lifting a book, climbing a flight of stairs, climbing up and down 4 flight of stairs, and performing a 360-degree turn. The score for each task ranges from 0 to 4; a perfect score is 36. Higher scores indicate better physical function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-11', 'size': 921362, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-24T15:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-01', 'studyFirstSubmitDate': '2015-01-21', 'resultsFirstSubmitDate': '2020-07-22', 'studyFirstSubmitQcDate': '2015-02-18', 'lastUpdatePostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-14', 'studyFirstPostDateStruct': {'date': '2015-02-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Total Testosterone Levels', 'timeFrame': 'Baseline and 6 months', 'description': 'as measured in the peripheral blood by liquid chromatography/mass spectrometry'}, {'measure': 'Change in Estradiol', 'timeFrame': 'Baseline and 6 months', 'description': 'As measured by LC-MS/MS'}, {'measure': 'Change in Hematocrit', 'timeFrame': 'Baseline and 6 months', 'description': 'the ratio of the volume of red blood cells to the total volume of blood.'}, {'measure': 'Change in Prostate Specific Antigen', 'timeFrame': 'Baseline and 6 months', 'description': 'blood test to screen for prostate cancer'}, {'measure': 'Change in Short Form Health Survey (SF-36) Quality of Life Physical Component', 'timeFrame': 'Baseline and 6 months', 'description': 'Using Short Form-36 of Life Questionnaire Physical Component subscale. Minimum score is 0, Maximum score is 100. Higher scores indicate better outcome.'}, {'measure': 'Change in International Prostate Symptom Score', 'timeFrame': 'Baseline and 6 months', 'description': 'Using the International Prostate Symptom Scoring (IPS); Minimum score is 0, Maximum score is 35. Higher scores mean worse outcome.'}, {'measure': 'Change in Triglyceride Levels', 'timeFrame': 'Baseline and 6 months', 'description': 'Blood samples obtained in the fasting state as part of measurements of lipid profile'}, {'measure': 'Change in HDL-cholesterol', 'timeFrame': 'Baseline and 6 months', 'description': 'Blood samples obtained in the fasting state as part of measurements of lipid profile'}, {'measure': 'Change in Waist Circumference', 'timeFrame': 'Baseline and 6 months', 'description': 'Waist circumference as measured horizontally at the midpoint between the highest point of the iliac crest and the lowest portion of the 12th rib in the standing position.'}, {'measure': 'Change in Glucose', 'timeFrame': 'Baseline and 6 months', 'description': 'Measured in the blood after overnight fast'}, {'measure': 'Change in Mood', 'timeFrame': 'Baseline and 6 months', 'description': 'Using Yesavage Depression Scale Lower scores indicate better mood (range 0 to 30).'}, {'measure': 'Number of Participants With Significant Changes in Functional Connectivity in the Default Mode Network', 'timeFrame': 'Baseline and 6 months', 'description': 'Functional connectivity was measured with seeds of the DMN (medial prefrontal cortex \\[MPFC\\] and posterior cingulate cortex \\[PCC\\]). Correlation coefficients representing the degree of connectivity between hypothesized regions were Fisher transformed. An a priori threshold of p\\<.001 at the voxel level and p\\<.05, FDR corrected for multiple comparisons across the whole brain, at the cluster level were used to determine significant connectivity.'}, {'measure': 'Change in Skeletal Muscle Growth Factor (MYOD1)', 'timeFrame': 'Baseline and 6 months', 'description': 'Assessed by using RNA-seq quantification of gene expression in skeletal muscles obtained during muscle biopsies.'}, {'measure': 'Change in Peripheral Quantitative Computed Tomography Measures (Volumetric Bone Density)', 'timeFrame': 'Baseline and 6 months', 'description': 'assessed by quantitative computed tomography at 4% distal tibia using the following thresholds: 180 mg/cm3 and 45% of the area'}], 'primaryOutcomes': [{'measure': 'Change in the Physical Performance Test', 'timeFrame': 'Baseline and 6 months', 'description': 'The primary functional outcome is the modified physical performance test, which includes seven standardized tasks (walking 50 ft, putting on and removing a coat, picking up a penny, standing up from a chair, lifting a book, climbing one flight of stairs, and performing a progressive Romberg tests) plus two additional tasks (climbing up and down four flights of stairs and performing a 360-degree turn). The score for each task ranges form 0 to 4; a perfect score is 36. Higher scores indicate better physical function.'}], 'secondaryOutcomes': [{'measure': 'Change in Endurance Capacity', 'timeFrame': 'Baseline and 6 months', 'description': 'Assessed by measuring peak oxygen consumption using indirect calorimetry during a treadmill exercise stress test'}, {'measure': 'Change in Functional Status', 'timeFrame': 'Baseline and 6 months', 'description': 'Assessed by the Functional Status Questionnaire. Score range: 0 to 36 with higher scores indicating better functional status\n\nProvides information of the participants ability to perform activities of daily living.'}, {'measure': 'Change in Body Weight', 'timeFrame': 'Baseline and 6 months', 'description': 'Measured after an overnight fast using calibrated scales'}, {'measure': 'Change in Lean Body Mass', 'timeFrame': 'Baseline and 6 months', 'description': 'Assessed by using dual-energy x-ray absorptiometry'}, {'measure': 'Change in Fat Mass', 'timeFrame': 'Baseline and 6 months', 'description': 'Assessed by using dual-energy x-ray absorptiometry'}, {'measure': 'Change in Thigh Muscle Volume', 'timeFrame': 'Baseline and 6 months', 'description': 'Assessed by using magnetic resonance imaging'}, {'measure': 'Thigh Fat Volume', 'timeFrame': '6 months', 'description': 'Volume of fat in the thigh by measured by magnetic resonance imaging'}, {'measure': 'Change in Total Hip Bone Mineral Density', 'timeFrame': 'Baseline and 6 months', 'description': 'Assessed by using dual-energy x-ray absorptiometry'}, {'measure': 'Change in Lumbar Spine Bone Mineral Density', 'timeFrame': 'Baseline and 6 months', 'description': 'As measured by Dual energy x-ray absorptiometry'}, {'measure': 'Change in Muscle Strength', 'timeFrame': 'Baseline and 6 months', 'description': 'assessed by total1-repetition maximum (the maximal weight lifted at one time; the totals are the sum of the maximal weights lifted in the biceps curl, bench press, 387 seated row, knee extension, knee flexion, and leg press exercises).'}, {'measure': 'Change in Static Balance', 'timeFrame': 'Baseline and 6 months', 'description': 'assessed by one leg limb stance'}, {'measure': 'Change in Dynamic Balance', 'timeFrame': 'Baseline and 6 months', 'description': 'Assessed by using the obstacle course'}, {'measure': 'Change in Gait Speed', 'timeFrame': 'Baseline and 6 months', 'description': 'Determined by measuring the time needed to walk 25 ft.'}, {'measure': 'Change in Composite Cognitive Z-score', 'timeFrame': 'Baseline and 6 months', 'description': 'Test of overall cognitive performance formed by averaging the standardized scores for several domains of cognitive function (attention, memory, executive, language, global). Higher scores indicate better cognitive status.\n\nThe Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of the baseline scores (units on a scale). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population'}, {'measure': 'Change in Modified Mini-mental Exam', 'timeFrame': 'Baseline and 6 months', 'description': 'Test of global cognition with components for orientation, registration, attention, language, praxis, and immediate and delayed memory. Score ranges from 0 to 100 with higher scores indicate better cognition.'}, {'measure': 'Stroop Interference', 'timeFrame': 'Baseline and 6 months', 'description': 'Assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.\n\nMinimum score is 0, there is no maximum value. Higher scores indicate better outcome.'}, {'measure': 'Change in Word List Fluency', 'timeFrame': 'Baseline and 6 months', 'description': 'Measure of verbal production, semantic memory, and language. Minimum score is 0, there is no maximum value. Higher scores indicate better outcome.'}, {'measure': 'Change in Ray Auditory Verbal Learning Test', 'timeFrame': 'Baseline and 6 months', 'description': 'The Rey Auditory Verbal Learning Test (RAVLT) evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information.\n\nMinimum score is 0, there is no maximum value. Higher scores indicate better outcome.'}, {'measure': 'Change in Trail A', 'timeFrame': 'Baseline and 6 months', 'description': 'Test of visuospatial scanning, speed of processing, mental flexibility, and executive function (with a greater focus on attention).\n\nMinimum score is 0, there is no maximum value. Higher scores indicate better outcome.'}, {'measure': 'Change in Trail B', 'timeFrame': 'Baseline and 6 months', 'description': 'Test of visuospatial scanning, speed of processing, mental flexibility, and executive function (with a focus on executive function)\n\nMinimum score is 0, there is no maximum value. Higher scores indicate better outcome.'}, {'measure': 'Change in Symbol Digital Modalities Test', 'timeFrame': 'Baseline and 6 months', 'description': 'Assesses key neurocognitive functions that underlie many substitution tasks, including attention, visual scanning, and motor speed.\n\nMinimum score is 0, there is no maximum value. Higher scores indicate better outcome.'}, {'measure': 'Change in Trabecular Bone Score', 'timeFrame': 'Baseline and 6 months', 'description': 'The trabecular bone score is a measure of bone texture correlated with bone microarchitecture and a marker for the risk of osteoporosis.\n\nMinimum score is 0, there is no maximum value. Higher scores indicate better bone microarchitecture.'}, {'measure': 'Change in C-terminal Telopeptide', 'timeFrame': 'Baseline and 6 months', 'description': 'biochemical marker of bone turnover (bone resorption) as measured by immunoassay technique'}, {'measure': 'Change in N-terminal Propeptide of Type I Procollagen', 'timeFrame': 'Baseline and 6 months', 'description': 'Biochemical marker of bone turnover (bone formation) as measured by radioimmunoassay technique'}, {'measure': 'Change in Insulin Growth Factor-1', 'timeFrame': 'Baseline and 6 months', 'description': 'Measured by immunoassay methodology'}, {'measure': 'Change in Trabecular Bone Score (Trabecular Bone Quality)', 'timeFrame': 'Baseline and 6 months', 'description': 'assessed by trabecular bone score (TBS), a newly developed index for assessing trabecular bone quality and fracture risk.\n\nTBS is a bone texture parameter that quantifies cancellous bone microachitecture, which is key in determining bone strength and resistance to fracture, by computing raw data from dual energy x-ray absorptiometry of the lumbar spine.\n\nThere are no minimum or maximum values. Higher scores mean better outcome.'}, {'measure': 'Change in Levels of 25-hydroxyvitamin D', 'timeFrame': 'Baseline and 6 months', 'description': 'assessed by using immunoassay methodology'}, {'measure': 'Change in Parathyroid Hormone Level', 'timeFrame': 'Baseline and 6 months', 'description': 'Measured by immunoassay methodology as marker of bone metabolism'}, {'measure': 'Change in High-sensitivity C-reactive Protein (Inflammatory Marker)', 'timeFrame': 'Baseline and 6 months', 'description': 'measured in the peripheral blood using immunoassay technique methodology'}, {'measure': 'Change in Interleukin-6', 'timeFrame': 'Baseline and 6 months', 'description': 'Measured from fasting serum using immunoassay technique as marker of inflammation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Hypogonadism', 'Frailty'], 'conditions': ['Obesity and Hypogonadism']}, 'referencesModule': {'references': [{'pmid': '34375393', 'type': 'DERIVED', 'citation': 'Gregori G, Celli A, Barnouin Y, Paudyal A, Armamento-Villareal R, Napoli N, Qualls C, Villareal DT. Cognitive response to testosterone replacement added to intensive lifestyle intervention in older men with obesity and hypogonadism: prespecified secondary analyses of a randomized clinical trial. Am J Clin Nutr. 2021 Nov 8;114(5):1590-1599. doi: 10.1093/ajcn/nqab253.'}]}, 'descriptionModule': {'briefSummary': 'The prevalence of obesity in Veterans is greater than in the general population, and even more so among users of the VA Health Care System. In addition, the population of obese older Veterans is rapidly increasing as more baby boomers become senior citizens. In older Veterans, obesity exacerbates the age- related decline in physical function and causes frailty which predisposes to admission to a VA chronic care facility. However, the optimal clinical approach to obesity in older adults is controversial because of the concern that weight loss therapy could be harmful by aggravating the age-related loss of muscle mass and bone mass. In fact, the MOVE (Managing Overweight/Obese Veterans) program does not have any guidelines for eligible Veterans if they are 70 or older. It is possible that the addition of testosterone replacement to lifestyle therapy will preserve muscle mass and bone mass and reverse frailty in obese older Veterans and thus prevent their loss of independence and decrease demand for VA health care services.', 'detailedDescription': 'Obesity is not only highly prevalent among Americans, but even more so among Veterans using VA medical facilities. Failure to assist Veterans in managing weight and sedentary lifestyle affects current treatment and increases future demand for VA health care services. Decreased muscle mass with aging and the need to carry extra mass due to obesity make it particularly difficult for obese older Veterans to function independently and results in frailty leading to increased nursing home admissions and increased morbidity and mortality. Data from preliminary studies showed that lifestyle therapy resulting in weight loss in this understudied population improves physical function and ameliorates frailty. However, this improvement in physical function is modest at best and most obese older adults remain physically frail. More importantly, there are concerns that lifestyle therapy may exacerbate underlying sarcopenia and osteopenia from weight loss- induced loss of lean body mass and bone mineral density (BMD). As a result, most geriatricians are reluctant to recommend lifestyle therapy that includes weight loss in obese frail elderly patients although the combination of weight loss and exercise is recommended as part of standard care for obese patients in general. Thus, it is not surprising that among Veterans, the MOVE (Managing Overweight/Obese Veterans) program does not have any guidelines for eligible Veterans if they are 70 or older. In addition to overeating and lack of exercise, age-related decline in anabolic hormone (i.e. testosterone) may contribute to sarcopenia and osteopenia, which in turn is exacerbated by obesity. Indeed, preliminary studies discovered that obese older men had markedly low levels of serum testosterone at baseline which remained low throughout the duration of lifestyle therapy. Because testosterone replacement therapy has been shown to increase muscle mass and BMD, it is therefore likely that concomitant testosterone replacement during lifestyle therapy in obese older adults would preserve lean body mass and BMD, and reverse frailty. Accordingly, the optimal management to the problem of sarcopenic obesity and frailty might require a comprehensive approach of a combination of lifestyle intervention and the correction of anabolic hormone deficiency. Therefore, the primary goal of this proposal is to conduct a randomized, comparative efficacy, double-blind, placebo-controlled (for testosterone) trial of the effects of 1) lifestyle therapy (1% diet-induced weight loss and exercise training) + testosterone replacement therapy versus 2) lifestyle therapy without testosterone replacement (testosterone placebo) in obese (BMI e 30 kg/m2) older (age e 65 yrs) male Veterans. The investigators hypothesize that 1) lifestyle therapy + testosterone replacement will cause a greater improvement in physical function than lifestyle therapy without concomitant testosterone replacement; 2) lifestyle therapy + testosterone replacement will cause a greater preservation of fat-free mass and thigh muscle volume than lifestyle therapy without testosterone replacement, 3) lifestyle therapy + testosterone replacement will cause a greater preservation in BMD and bone quality than lifestyle therapy without testosterone replacement, and 4) lifestyle therapy + testosterone replacement will cause a greater reduction in intramuscular proinflammatory cytokines than lifestyle therapy without testosterone replacement. The overarching hypothesis across aims is that a multifactorial intervention by means of lifestyle therapy plus testosterone replacement will be the most effective approach for reversing sarcopenic obesity and frailty in obese older male adults, as mediated by their additive effects in suppressing chronic inflammation, and stimulating muscle and bone anabolism. Obesity in older adults, including many aging Veterans, is a major public health problem. In fact, the public health success that has occurred in recent years could be in danger if lifestyles of older adults are neglected. The novel health outcomes and mechanistic-based data generated from this proposed randomized clinical trial (RCT) will have important ramifications for the standard of care for this rapidly increasing segment of the aging Veteran population.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'genderBased': True, 'genderDescription': 'Male', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects will be\n\n* older (65-85 yr)\n* obese (BMI 30 kg/m2 or greater) Veteran men with low testosterone (less than 300 mg/dL) as defined by the Endocrine Society\n* mild to moderately frail\n* must have stable weight (\\~not less than or more than 2 kg) during the last 6 months\n* sedentary (regular exercise less than 1 h/week or less than 2x/week for the last 6 months)\n\nExclusion Criteria:\n\n* Any major chronic diseases, or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results.\n* Examples include, but are not limited to:\n\n * cardiopulmonary disease (e.g. recent myocardial infarction (MI), unstable angina, stroke etc) or unstable disease (e.g. CHF)\n * severe orthopedic/musculoskeletal or neuromuscular impairments\n * visual or hearing impairments\n * cognitive impairment (Mini Mental State Exam Score less than 24)\n * current use of bone active drugs\n * uncontrolled diabetes (i.e. fasting blood glucose more than 140 mg/dl and/or HbA1c greater than 9.5%).\n* Any contraindications to testosterone supplementation\n\n * history of prostate or breast cancer\n * history of testicular disease\n * untreated sleep apnea\n * hematocrit more than 50%\n * prostate-related findings of palpable nodule on exam, a serum PSA of 4.0 ng/ml or greater\n * International Prostate Symptom Sore more than 19\n * history of venous thromboembolism\n* Osteoporosis or a BMD T-score of -2.5 in the lumbar spine or total hip as well as those patients with a history of osteoporosis-related fracture (spine, hip, or wrist)'}, 'identificationModule': {'nctId': 'NCT02367105', 'acronym': 'LITROS', 'briefTitle': 'Lifestyle Intervention and Testosterone Replacement in Obese Seniors', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Testosterone Replacement to Augment Lifestyle Therapy in Obese Older Veterans', 'orgStudyIdInfo': {'id': 'ENDA-034-12F'}, 'secondaryIdInfos': [{'id': 'CX000906', 'type': 'OTHER_GRANT', 'domain': 'VA CSRD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Testosterone plus Lifestyle Therapy', 'description': 'Testosterone replacement in combination with behavioral diet to induce \\~10% weight loss + supervised aerobic and exercise training', 'interventionNames': ['Drug: Testosterone', 'Other: Lifestyle Therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo plus Lifestyle Therapy', 'description': 'Placebo in combination with behavioral diet to induce \\~10% weight loss and supervised aerobic and exercise training', 'interventionNames': ['Other: Lifestyle Therapy', 'Drug: Placebo']}], 'interventions': [{'name': 'Testosterone', 'type': 'DRUG', 'description': 'Daily testosterone gel applied once daily in the morning to intact skin', 'armGroupLabels': ['Testosterone plus Lifestyle Therapy']}, {'name': 'Lifestyle Therapy', 'type': 'OTHER', 'description': 'Weekly behavioral diet to induce \\~10% weight loss in combination with supervised aerobic and exercise training three times a week', 'armGroupLabels': ['Placebo plus Lifestyle Therapy', 'Testosterone plus Lifestyle Therapy']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo gel for testosterone', 'armGroupLabels': ['Placebo plus Lifestyle Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael E. DeBakey VA Medical Center, Houston, TX', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Dennis T Villareal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michael E. DeBakey VA Medical Center, Houston, TX'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Publications from this research will be made available to the public through the National Library of Medicine PubMed Central website within one year after the date of publication (guidance is provided on the ORD website).\n\nMEDVAMC will not provide unrestricted, open public access to large scale health related datasets because of re-identification concerns and the obligation to protect Veterans' private information. However, controlled public access will be provided to the greatest extent possible under specific DUAs or other written agreements, and open access will be provided to the final datasets underlying peer-reviewed publications (aggregated data that can be released with privacy and confidentiality risks)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'Michael E. DeBakey VA Medical Center', 'class': 'FED'}, {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, {'name': 'Biomedical Research Institute of New Mexico', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}