Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-29 @ 2:01 PM
Study NCT ID:
NCT03256292
Status:
COMPLETED
Last Update Posted:
2021-03-10
First Post:
2017-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Lifestyle Change and Testosterone Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007006', 'term': 'Hypogonadism'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-08', 'studyFirstSubmitDate': '2017-08-16', 'studyFirstSubmitQcDate': '2017-08-17', 'lastUpdatePostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Physical Performance Test score', 'timeFrame': '18 month', '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.'}, {'measure': 'Change in body weight', 'timeFrame': '18 month', 'description': 'Measured after an overnight fast using calibrated scales'}], 'secondaryOutcomes': [{'measure': 'Change in body composition (lean mass, fat mass and bone mineral density)', 'timeFrame': '18 month', 'description': 'Assessed by using dual-energy x-ray absorptiometry'}, {'measure': 'Volumetric BMD', 'timeFrame': '18 month', 'description': 'Assessed by using peripheral quantitative computed tomography (pQCT)'}, {'measure': 'Biochemical Markers of Bone Turnover (Serum C-terminal telopeptide (CTX)', 'timeFrame': '18 month', 'description': 'measured by ELISA'}, {'measure': 'Change in prostate specific antigen', 'timeFrame': '18 month', 'description': 'measured in the blood'}, {'measure': 'Prostate Symptom Assessment', 'timeFrame': '18 month', 'description': 'Using the International Prostate Symptom Scoring'}, {'measure': 'Mood', 'timeFrame': '18 month', 'description': 'Using the Geriatric Depression Scale'}, {'measure': 'Quality of Life', 'timeFrame': '18 month', 'description': 'Using SF-36 and impact of weight on quality of life short form (IWQOL-lite)'}, {'measure': 'Sexual function', 'timeFrame': '18 month', 'description': 'Using the International Index of Erectile Function'}, {'measure': 'Change in trabecular bone score', 'timeFrame': '18 month', 'description': 'Using DXA'}, {'measure': 'Change in muscle strength and quality', 'timeFrame': '18 month', 'description': 'Using biodex dynamometry'}, {'measure': 'Change in balance', 'timeFrame': '18 month', 'description': 'as measured by leg stance and obstacle course'}, {'measure': 'Change in Functional Status', 'timeFrame': '18 month', 'description': 'Using functional status questionnaire'}, {'measure': 'Change in gait', 'timeFrame': '18 month', 'description': 'as measured by completing the time to walk a certain distance'}, {'measure': 'Change in bone quality', 'timeFrame': '18 month', 'description': 'Using HrpQCT'}, {'measure': 'Change in testosterone level', 'timeFrame': '18 month', 'description': 'as measured in the blood'}, {'measure': 'Change in sex hormone globulin', 'timeFrame': '18 month', 'description': 'as measured in the blood'}, {'measure': 'Change in metabolic hormones', 'timeFrame': '18 month', 'description': 'Leptin, adiponectin, and similar metabolic hormones as measured in the blood'}, {'measure': 'Change in Composite cognitive z-score', 'timeFrame': '18 month', 'description': 'using cognitive instrument testing'}, {'measure': 'Change in Modified mini-mental exam', 'timeFrame': '18 month', 'description': 'using cognitive instrument testing'}, {'measure': 'Change in Stroop color naming', 'timeFrame': '18 month', 'description': 'using cognitive instrument testing'}, {'measure': 'Change in Word list fluency', 'timeFrame': '18 month', 'description': 'using cognitive instrument testing'}, {'measure': 'Change in Ray auditory verbal learning test', 'timeFrame': '18 month', 'description': 'using cognitive instrument testing'}, {'measure': 'Change in Trail A/B', 'timeFrame': '18 month', 'description': 'using cognitive instrument testing'}, {'measure': 'Change in waist circumference', 'timeFrame': '18 month', 'description': 'as measured'}, {'measure': 'Change in serum PTH', 'timeFrame': '18 month', 'description': 'as measured in the blood'}, {'measure': 'Change in lipid profile', 'timeFrame': '18 month', 'description': 'as measured in the blood'}, {'measure': 'Change in blood pressure', 'timeFrame': '18 month', 'description': 'as measured by sphygmomanometry'}, {'measure': 'Change in metabolic syndrome', 'timeFrame': '18 month', 'description': 'using harmonized metabolic syndrome criteria'}, {'measure': 'bone strength index', 'timeFrame': '18 months', 'description': 'assessed by pQCT'}, {'measure': 'Cortical to total area', 'timeFrame': '18 months', 'description': 'assessed by pQCT'}, {'measure': 'Change in density weighted polar section modulus', 'timeFrame': '18 months', 'description': 'assessed by pQCT'}, {'measure': 'Change in cortical density', 'timeFrame': '18 months', 'description': 'assessed by pQCT'}, {'measure': 'Change in cortical area', 'timeFrame': '18 months', 'description': 'assessed by pQCT'}, {'measure': 'Change in Biochemical Markers of Bone Turnover (PINP)', 'timeFrame': '18 months', 'description': 'measured by RIA'}, {'measure': 'Change in lipid profile', 'timeFrame': '18 months', 'description': 'measured in the blood'}, {'measure': 'Change in vitamin D level', 'timeFrame': '18 months', 'description': 'measured in the blood'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypogonadism', 'Aging', 'Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'Older hypogonadal obese veterans previously participated in a 6 month lifestyle change (diet-induced weight loss and exercise) study with or without testosterone replacement therapy before being followed for the following year at the clinic while receiving standard of care consisting of diet and exercise counseling (for healthy lifestyle change) and testosterone replacement therapy. This study will determine if long-term lifestyle change and testosterone replacement therapy with associated improvement in physical and metabolic health can be maintained in obese older adults.', 'detailedDescription': 'Background: There are studies on long-term testosterone replacement in older adults with hypogonadism showing benefits on body composition, sexual function and mood but not on testosterone replacement therapy in combination with lifestyle change (diet-induced weight loss and exercise) in the specific population of older adults with both obesity and hypogonadism.\n\nPurpose: To determine if long-term lifestyle change and testosterone replacement therapy with associated improvement in physical and metabolic health can be maintained in obese older adults .\n\nDesign: Overweight/obese older veteran patients with obesity and hypogonadism who are being followed at the endocrine clinic while receiving standard of care consisting of diet and exercise counseling (for healthy lifestyle change) and testosterone replacement therapy will be recruited for testing of physical, metabolic, cognitive/mood, quality of life, and body composition testing.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Older adults with hypogonadism following lifestyle change (diet and exercise on their own for at least one year) with testosterone replacement therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Overweight/obese (BMI = or \\> 27 kg/m2)\n* Older (65-85 yr)\n* Male veteran patients being seen at the PI's endocrine clinic and receiving standard of care consisting of diet and regular exercise counseling\n* Diagnosed with hypogonadism on current or previous testosterone replacement at the PI's endocrine clinic\n* Willing to provide informed consent\n\nExclusion Criteria:\n\n* Failure to provide informed consent\n* Unstable cardiopulmonary disease (e.g. recent MI, unstable angina, stroke) or unstable disease (Class III or IV congestive heart failure)."}, 'identificationModule': {'nctId': 'NCT03256292', 'acronym': 'LITE', 'briefTitle': 'Long-term Lifestyle Change and Testosterone Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Long-term Lifestyle Change in Obese Older Veterans', 'orgStudyIdInfo': {'id': 'H-40598'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'testosterone, diet, and increased physical activity', 'description': 'Group receiving standard of care consisting of diet and regular exercise counseling + testosterone replacement therapy', 'interventionNames': ['Drug: Testosterone replacement', 'Behavioral: lifestyle']}], 'interventions': [{'name': 'Testosterone replacement', 'type': 'DRUG', 'description': 'Testosterone replacement therapy', 'armGroupLabels': ['testosterone, diet, and increased physical activity']}, {'name': 'lifestyle', 'type': 'BEHAVIORAL', 'description': 'lifestyle intervention consisting of diet and increased physical activity', 'armGroupLabels': ['testosterone, diet, and increased physical activity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael E DeBakey VA Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Dennis T Villareal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Controlled access requests 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 in accordance with the research disposition policy which states that research records will be destroyed 6 years after cutoff (at the end of the fiscal year) after completion of the research project, but may be retained longer if required by other federal regulations or sponsor archive requirements.', 'ipdSharing': 'YES', 'description': 'A De-identified, Anonymized Dataset will be created and shared. NOTE: ORO recommends that such sharing take place under a written agreement that adheres to any applicable Informed Consent provisions and prohibits the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. However, it is permissible for final datasets in machine-readable format to be submitted to and accessed from PubMed Central (and similar sites) provided that care is taken to ensure that the individuals cannot be re-identified using other publicly available information.', 'accessCriteria': 'Controlled access requests 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 in accordance with the research disposition policy which states that research records will be destroyed 6 years after cutoff (at the end of the fiscal year) after completion of the research project, but may be retained longer if required by other federal regulations or sponsor archive requirements.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dennis T. Villareal', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}