Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2026-01-27 @ 3:30 AM
Study NCT ID:
NCT03118050
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2016-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Identifying Therapeutic Targets of Accelerated Sarcopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}, {'id': 'D001510', 'term': 'Bed Rest'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'volpi@uthscsa.edu', 'phone': '210-562-6139', 'title': 'Elena Volpi, MD, PhD', 'organization': 'University of Texas Medical Branch'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored from baseline through 1 week following completion of the intervention period.', 'eventGroups': [{'id': 'EG000', 'title': 'Resistance Training in Type 2 Diabetes (T2DM)', 'description': 'Type 2 diabetes subjects will undergo 3 months of resistance exercise training. Muscle size, strength and response to a low dose amino acids will be measured before and after training. Results of this arm will be compared to those previously obtained in healthy older subjects who participated in NCT02999802 (same training protocol) after 1:1 matching for age and sex.\n\nResistance exercise training: Supervised resistance exercise training, 3 times a week for 3 months', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bed Rest in Healthy Subjects, Low-dose Amino Acids (LAA)', 'description': 'Healthy subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Bed Rest in Healthy Subjects, High-dose Amino Acids (HAA)', 'description': 'Healthy subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a high dose amino acids (HAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Bed Rest in Type 2 Diabetes (T2DM), Low-dose Amino Acids (LAA)', 'description': 'Type 2 diabetes (T2DM) subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Bed Rest in Type 2 Diabetes (T2DM), High-dose Amino Acids (HAA)', 'description': 'Type 2 diabetes (T2DM) subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a high dose amino acids (HAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Bed Rest in Healthy Subjects, Physical Therapy (PT)Subjects, PT', 'description': 'Healthy subjects will undergo short term bed rest with intensive physical therapy (PT). Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days\n\nIntensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB IRB 17-0064', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Bed Rest in Type 2 Diabetes (T2DM), Physical Therapy (PT)', 'description': 'Type 2 diabetes (T2DM) subjects will undergo short term bed rest with intensive physical therapy (PT). Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days\n\nIntensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB IRB 17-0064', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Home medication error', 'notes': 'The participant accidentally took a double dose of prescribed blood pressure medication.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Leg Lean Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Training in Type 2 Diabetes (T2DM)', 'description': 'Type 2 diabetes subjects will undergo 3 months of resistance exercise training. Muscle size, strength and response to a low dose amino acids will be measured before and after training. Results of this arm will be compared to those previously obtained in healthy older subjects who participated in NCT02999802 (same training protocol) after 1:1 matching for age and sex.\n\nResistance exercise training: Supervised resistance exercise training, 3 times a week for 3 months'}, {'id': 'OG001', 'title': 'Bed Rest in Healthy Subjects, Low-dose Amino Acids (LAA)', 'description': 'Healthy subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064'}, {'id': 'OG002', 'title': 'Bed Rest in Healthy Subjects, High-dose Amino Acids (HAA)', 'description': 'Healthy subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a high dose amino acids (HAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064'}, {'id': 'OG003', 'title': 'Bed Rest in Type 2 Diabetes (T2DM), Low-dose Amino Acids (LAA)', 'description': 'Type 2 diabetes (T2DM) subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064'}, {'id': 'OG004', 'title': 'Bed Rest in Type 2 Diabetes (T2DM), High-dose Amino Acids (HAA)', 'description': 'Type 2 diabetes (T2DM) subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a high dose amino acids (HAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064'}, {'id': 'OG005', 'title': 'Bed Rest in Healthy Subjects, Physical Therapy (PT)', 'description': 'Healthy subjects will undergo short term bed rest with intensive physical therapy (PT). Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days\n\nIntensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB IRB 17-0064'}, {'id': 'OG006', 'title': 'Bed Rest in Type 2 Diabetes (T2DM), Physical Therapy (PT)', 'description': 'Type 2 diabetes (T2DM) subjects will undergo short term bed rest with intensive physical therapy (PT). Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days\n\nIntensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB 17-0064'}], 'classes': [{'categories': [{'measurements': [{'value': '0.35', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '-0.80', 'spread': '0.44', 'groupId': 'OG002'}, {'value': '-0.44', 'spread': '0.32', 'groupId': 'OG003'}, {'value': '-0.66', 'spread': '0.31', 'groupId': 'OG004'}, {'value': '-0.59', 'spread': '0.73', 'groupId': 'OG005'}, {'value': '-0.40', 'spread': '0.34', 'groupId': 'OG006'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006'], 'pValueComment': 'Main effect of bed rest.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to up to 3 months', 'description': 'Measurement of change in leg lean mass by DEXA', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Knee Extension Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Training in Type 2 Diabetes (T2DM)', 'description': 'Type 2 diabetes subjects will undergo 3 months of resistance exercise training. Muscle size, strength and response to a low dose amino acids will be measured before and after training. Results of this arm will be compared to those previously obtained in healthy older subjects who participated in NCT02999802 (same training protocol) after 1:1 matching for age and sex.\n\nResistance exercise training: Supervised resistance exercise training, 3 times a week for 3 months'}, {'id': 'OG001', 'title': 'Bed Rest in Healthy Subjects, Low-dose Amino Acids (LAA)', 'description': 'Healthy subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064'}, {'id': 'OG002', 'title': 'Bed Rest in Healthy Subjects, High-dose Amino Acids (HAA)', 'description': 'Healthy subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a high dose amino acids (HAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064'}, {'id': 'OG003', 'title': 'Bed Rest in Type 2 Diabetes (T2DM), Low-dose Amino Acids (LAA)', 'description': 'Type 2 diabetes (T2DM) subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064'}, {'id': 'OG004', 'title': 'Bed Rest in Type 2 Diabetes (T2DM), High-dose Amino Acids (HAA)', 'description': 'Type 2 diabetes (T2DM) subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a high dose amino acids (HAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064'}, {'id': 'OG005', 'title': 'Bed Rest in Healthy Subjects, Physical Therapy (PT)', 'description': 'Healthy subjects will undergo short term bed rest with intensive physical therapy (PT). Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days\n\nIntensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB IRB 17-0064'}, {'id': 'OG006', 'title': 'Bed Rest in Type 2 Diabetes (T2DM), Physical Therapy (PT)', 'description': 'Type 2 diabetes (T2DM) subjects will undergo short term bed rest with intensive physical therapy (PT). Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days\n\nIntensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB 17-0064'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '11', 'groupId': 'OG000'}, {'value': '-12', 'spread': '20', 'groupId': 'OG001'}, {'value': '-24', 'spread': '16', 'groupId': 'OG002'}, {'value': '-23', 'spread': '13', 'groupId': 'OG003'}, {'value': '-30', 'spread': '14', 'groupId': 'OG004'}, {'value': '-14', 'spread': '9', 'groupId': 'OG005'}, {'value': '-8', 'spread': '22', 'groupId': 'OG006'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006'], 'pValueComment': 'Main effect of bed rest', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to up to 3 months', 'description': 'Measurement of change in maximum strength by standard method', 'unitOfMeasure': 'Nm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Amino Acid Transporter Expression', 'timeFrame': 'Change from baseline to up to 3 months', 'description': 'Measurement of change in amino acid transporter expression', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-10'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Muscle Protein Synthesis', 'timeFrame': 'Change from baseline to up to 3 months', 'description': 'Measurement of change in muscle protein synthesis by standard stable isotope methodology', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Resistance Training in Type 2 Diabetes (T2DM)', 'description': 'Type 2 diabetes subjects will undergo 3 months of resistance exercise training. Muscle size, strength and response to a low dose amino acids will be measured before and after training. Results of this arm will be compared to those previously obtained in healthy older subjects who participated in NCT02999802 (same training protocol) after 1:1 matching for age and sex.\n\nResistance exercise training: Supervised resistance exercise training, 3 times a week for 3 months'}, {'id': 'FG001', 'title': 'Bed Rest in Healthy Subjects, Low-dose Amino Acids (LAA)', 'description': 'Healthy subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064'}, {'id': 'FG002', 'title': 'Bed Rest in Healthy Subjects, High-dose Amino Acids (HAA)', 'description': 'Healthy subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a high dose amino acids (HAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064'}, {'id': 'FG003', 'title': 'Bed Rest in Type 2 Diabetes (T2DM), Low-dose Amino Acids (LAA)', 'description': 'Type 2 diabetes (T2DM) subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days'}, {'id': 'FG004', 'title': 'Bed Rest in Type 2 Diabetes (T2DM), High-dose Amino Acids (HAA)', 'description': 'Type 2 diabetes (T2DM) subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a high dose amino acids (HAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days'}, {'id': 'FG005', 'title': 'Bed Rest in Healthy Subjects, Physical Therapy (PT)', 'description': 'Healthy subjects will undergo short term bed rest with intensive physical therapy (PT). Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days\n\nIntensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB IRB 17-0064'}, {'id': 'FG006', 'title': 'BR in T2DM, PT', 'description': 'Type 2 diabetes (T2DM) subjects will undergo short term bed rest with intensive physical therapy (PT). Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days\n\nIntensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB IRB 17-0064'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Did not meet inclusion criteria after signing consent form', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Eligible participants were randomized to one of six bed rest (BR) study arms under IRB protocol 17-0064. Separately, eligible participants were randomized to one of six resistance training (RT) study arms under IRB protocol 15-0229. The RT data were analyzed in comparison with de-identified data obtained from NTC02999802.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '50', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Resistance Training in Type 2 Diabetes (T2DM)', 'description': 'Type 2 diabetes subjects will undergo 3 months of resistance exercise training. Muscle size, strength and response to a low dose amino acids will be measured before and after training. Results of this arm will be compared to those previously obtained in healthy older subjects who participated in NCT02999802 (same training protocol) after 1:1 matching for age and sex.\n\nResistance exercise training: Supervised resistance exercise training, 3 times a week for 3 months'}, {'id': 'BG001', 'title': 'Bed Rest in Healthy Subjects, Low-dose Amino Acids (LAA)', 'description': 'Healthy subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064'}, {'id': 'BG002', 'title': 'Bed Rest in Healthy Subjects, High-dose Amino Acids (HAA)', 'description': 'Healthy subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a high dose amino acids (HAA) will be measured. before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064'}, {'id': 'BG003', 'title': 'Bed Rest in Type 2 Diabetes (T2DM), Low-dose Amino Acids (LAA)', 'description': 'Type 2 diabetes (T2DM) subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064'}, {'id': 'BG004', 'title': 'Bed Rest in Type 2 Diabetes (T2DM), High-dose Amino Acids (HAA)', 'description': 'Type 2 diabetes (T2DM) subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a high dose amino acids (HAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064'}, {'id': 'BG005', 'title': 'Bed Rest in Healthy Subjects, Physical Therapy (PT)', 'description': 'Healthy subjects will undergo short term bed rest with intensive physical therapy (PT). Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days\n\nIntensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB IRB 17-0064'}, {'id': 'BG006', 'title': 'Bed Rest in Type 2 Diabetes (T2DM), Physical Therapy (PT)', 'description': 'Type 2 diabetes (T2DM) subjects will undergo short term bed rest with intensive physical therapy (PT). Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.\n\nBed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days\n\nIntensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB IRB 17-0064'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68', 'spread': '4', 'groupId': 'BG000'}, {'value': '67', 'spread': '7', 'groupId': 'BG001'}, {'value': '73', 'spread': '6', 'groupId': 'BG002'}, {'value': '70', 'spread': '5', 'groupId': 'BG003'}, {'value': '71', 'spread': '8', 'groupId': 'BG004'}, {'value': '64', 'spread': '1', 'groupId': 'BG005'}, {'value': '68', 'spread': '6', 'groupId': 'BG006'}, {'value': '69', 'spread': '6', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '27', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '23', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '44', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '45', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '50', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-04', 'size': 351629, 'label': 'Study Protocol: 15-0229 Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-10-29T14:03', 'hasProtocol': True}, {'date': '2023-01-25', 'size': 616486, 'label': 'Study Protocol and Statistical Analysis Plan: 17-0064 Study Protocol', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-11-20T19:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'dispFirstSubmitDate': '2024-06-05', 'completionDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2016-12-08', 'resultsFirstSubmitDate': '2025-10-16', 'studyFirstSubmitQcDate': '2017-04-12', 'dispFirstPostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-20', 'studyFirstPostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Amino Acid Transporter Expression', 'timeFrame': 'Change from baseline to up to 3 months', 'description': 'Measurement of change in amino acid transporter expression'}, {'measure': 'Muscle Protein Synthesis', 'timeFrame': 'Change from baseline to up to 3 months', 'description': 'Measurement of change in muscle protein synthesis by standard stable isotope methodology'}], 'primaryOutcomes': [{'measure': 'Leg Lean Mass', 'timeFrame': 'Change from baseline to up to 3 months', 'description': 'Measurement of change in leg lean mass by DEXA'}], 'secondaryOutcomes': [{'measure': 'Knee Extension Strength', 'timeFrame': 'Change from baseline to up to 3 months', 'description': 'Measurement of change in maximum strength by standard method'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'bed rest', 'muscle', 'nutrition', 'amino acids'], 'conditions': ['Sarcopenia', 'Diabetes Mellitus', 'Aging']}, 'descriptionModule': {'briefSummary': "The proposed research is designed to identify the mechanisms that can accelerate loss of muscle size, strength and physical function in type 2 diabetes and with hospitalization in older persons. About ⅓ of older Americans have type 2 diabetes, and about ⅓ of the hospitalizations in the USA involve persons older than 65 year of age. The proposed research is relevant to the part of NIH's mission that pertains to development of the fundamental knowledge that will improve health and reduce the burdens of disability, because this work will provide the fundamental evidence to identify new targets for the development of innovative treatments to slow down muscle loss and disability in our aging society.", 'detailedDescription': 'Sarcopenia is a major contributor to frailty and increases the risk of falls, physical dependence, disability and mortality in older adults. It advances slowly with healthy aging. However, diseases or other insults and injuries can accelerate sarcopenia and lead to catastrophic declines in mobility and independence. For example, chronic diseases such as Type 2 Diabetes Mellitus (T2DM) are associated with accelerated loss of muscle mass and function in seniors; hospitalization with bed rest inactivity acutely accelerates sarcopenia. What it is not known is how concurrent diseases, inactivity or other insults and injuries accelerate sarcopenia in older adults. This knowledge gap hinders the development of innovative, targeted treatments for this disabling condition. The objective of this research is to examine the basic mechanisms that underlie accelerated sarcopenia in older adults and identify potential targets for interventions. The central hypothesis is that a global and fundamental mechanism of acute or chronic acceleration of sarcopenia is a reduction in skeletal muscle amino acid transport, which decreases muscle protein anabolism, and can be reversed by activation of the mammalian/mechanistic Target of Rapamycin Complex 1 (mTORC1) signaling with a non-amino acid stimulus, such as exercise. Amino acid transport is an active process that controls intracellular amino acid availability and the activation of protein synthesis in skeletal muscle. It is regulated by amino acid concentrations and non-amino acid stimuli that activate mTORC1 signaling, such as resistance exercise and insulin.The central hypothesis will be tested with the following specific aims: 1) Determine the effect of T2DM on the sensitivity of skeletal muscle amino acid transport to dietary amino acids. 2) Determine the effect of short-term bed rest inactivity on the sensitivity of skeletal muscle amino acid transport to dietary amino acids. 3) Determine the effect of resistance exercise on the sensitivity of amino acid transport to dietary amino acids in acute and chronic accelerated sarcopenia induced by inactivity or T2DM. Amino acid transport and protein metabolism in muscle will be measured using integrative molecular, imaging and stable isotope methodologies, identifying specific upstream regulators involved in the anabolic resistance of accelerated sarcopenia that can be targeted with novel treatments to reduce sarcopenia and improve independence in older adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index: \\<40 kg/sq meter\n* Score ≥26 on the 30-item Mini Mental State Examination\n* Stable body weight for at least 3 months\n* Non-diabetic or with Type 2 Diabetes Mellitus\n\nExclusion Criteria:\n\n* Pre-diabetes per American Diabetes Association criteria\n* Insulin therapy, significant diabetic complications, or A1c\\>8%\n* Impairment in Activities of Daily Living\n* \\>2 falls/year\n* weight loss \\>5% in the past 6 months\n* Exercise training (≥2 sessions/week) or ≥10,000 steps/day\n* Significant cardiovascular, liver, renal, blood, or respiratory disease\n* Active cancer or infection\n* Recent (within 3 months) treatment with anabolic steroids, systemic corticosteroids or estrogen.\n* Alcohol or drug abuse'}, 'identificationModule': {'nctId': 'NCT03118050', 'briefTitle': 'Identifying Therapeutic Targets of Accelerated Sarcopenia', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Identifying Therapeutic Targets of Accelerated Sarcopenia', 'orgStudyIdInfo': {'id': '15-0229/17-0064'}, 'secondaryIdInfos': [{'id': 'R01AG049611', 'link': 'https://reporter.nih.gov/quickSearch/R01AG049611', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RT in T2DM', 'description': 'Type 2 diabetes subjects will undergo 3 months of resistance exercise training. Muscle size, strength and response to a low dose amino acids will be measured before and after training. Results of this arm will be compared to those previously obtained in healthy older subjects who participated in NCT02999802 (same training protocol) after 1:1 matching for age and sex.', 'interventionNames': ['Behavioral: Resistance exercise training']}, {'type': 'EXPERIMENTAL', 'label': 'BR in healthy subjects, LAA', 'description': 'Healthy subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.', 'interventionNames': ['Behavioral: Bed rest']}, {'type': 'EXPERIMENTAL', 'label': 'BR in healthy subjects, HAA', 'description': 'Healthy subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a high dose amino acids (HAA) will be measured before and after bed rest.', 'interventionNames': ['Behavioral: Bed rest']}, {'type': 'EXPERIMENTAL', 'label': 'BR in T2DM, LAA', 'description': 'Type 2 diabetes (T2DM) subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.', 'interventionNames': ['Behavioral: Bed rest']}, {'type': 'EXPERIMENTAL', 'label': 'BR in T2DM, HAA', 'description': 'Type 2 diabetes (T2DM) subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a high dose amino acids (HAA) will be measured before and after bed rest.', 'interventionNames': ['Behavioral: Bed rest']}, {'type': 'EXPERIMENTAL', 'label': 'BR in healthy subjects, PT', 'description': 'Healthy subjects will undergo short term bed rest with intensive physical therapy (PT). Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.', 'interventionNames': ['Behavioral: Bed rest', 'Behavioral: Intensive physical therapy']}, {'type': 'EXPERIMENTAL', 'label': 'BR in T2DM, PT', 'description': 'Type 2 diabetes (T2DM) subjects will undergo short term bed rest with intensive physical therapy (PT). Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.', 'interventionNames': ['Behavioral: Bed rest', 'Behavioral: Intensive physical therapy']}], 'interventions': [{'name': 'Resistance exercise training', 'type': 'BEHAVIORAL', 'otherNames': ['RT'], 'description': 'Supervised resistance exercise training, 3 times a week for 3 months', 'armGroupLabels': ['RT in T2DM']}, {'name': 'Bed rest', 'type': 'BEHAVIORAL', 'otherNames': ['BR'], 'description': 'Bed rest for 5 days, followed by standard rehabilitation for 2 days', 'armGroupLabels': ['BR in T2DM, HAA', 'BR in T2DM, LAA', 'BR in T2DM, PT', 'BR in healthy subjects, HAA', 'BR in healthy subjects, LAA', 'BR in healthy subjects, PT']}, {'name': 'Intensive physical therapy', 'type': 'BEHAVIORAL', 'otherNames': ['PT'], 'description': 'Intensive weight bearing PT, daily, during bed rest', 'armGroupLabels': ['BR in T2DM, PT', 'BR in healthy subjects, PT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77550', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'Sealy Center on Aging, University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'Elena Volpi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTMB'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Small physiological study. Few subjects. Risk of loss of confidentiality'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}