Trial Outcomes & Findings for Identifying Therapeutic Targets of Accelerated Sarcopenia (NCT NCT03118050)

NCT ID: NCT03118050

Last Updated: 2025-12-05

Results Overview

Measurement of change in leg lean mass by DEXA

Recruitment status

COMPLETED

Study phase

Target enrollment

95 participants

Primary outcome timeframe

Change from baseline to up to 3 months

Results posted on

2025-12-05

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Resistance Training in Type 2 Diabetes (T2DM) 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. Resistance exercise training: Supervised resistance exercise training, 3 times a week for 3 months	Bed Rest in Healthy Subjects, Low-dose Amino Acids (LAA) 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064	Bed Rest in Healthy Subjects, High-dose Amino Acids (HAA) 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064	Bed Rest in Type 2 Diabetes (T2DM), Low-dose Amino Acids (LAA) 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days	Bed Rest in Type 2 Diabetes (T2DM), High-dose Amino Acids (HAA) 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days	Bed Rest in Healthy Subjects, Physical Therapy (PT) 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days Intensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB IRB 17-0064	BR in T2DM, PT 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days Intensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB IRB 17-0064
Overall Study STARTED	29	12	11	11	9	12	11
Overall Study COMPLETED	15	7	5	6	5	6	6
Overall Study NOT COMPLETED	14	5	6	5	4	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Resistance Training in Type 2 Diabetes (T2DM) 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. Resistance exercise training: Supervised resistance exercise training, 3 times a week for 3 months	Bed Rest in Healthy Subjects, Low-dose Amino Acids (LAA) 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064	Bed Rest in Healthy Subjects, High-dose Amino Acids (HAA) 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064	Bed Rest in Type 2 Diabetes (T2DM), Low-dose Amino Acids (LAA) 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days	Bed Rest in Type 2 Diabetes (T2DM), High-dose Amino Acids (HAA) 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days	Bed Rest in Healthy Subjects, Physical Therapy (PT) 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days Intensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB IRB 17-0064	BR in T2DM, PT 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days Intensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB IRB 17-0064
Overall Study Did not meet inclusion criteria after signing consent form	14	5	6	5	4	6	5

Baseline Characteristics

Identifying Therapeutic Targets of Accelerated Sarcopenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Resistance Training in Type 2 Diabetes (T2DM) n=15 Participants 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. Resistance exercise training: Supervised resistance exercise training, 3 times a week for 3 months	Bed Rest in Healthy Subjects, Low-dose Amino Acids (LAA) n=7 Participants 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064	Bed Rest in Healthy Subjects, High-dose Amino Acids (HAA) n=5 Participants 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064	Bed Rest in Type 2 Diabetes (T2DM), Low-dose Amino Acids (LAA) n=6 Participants 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064	Bed Rest in Type 2 Diabetes (T2DM), High-dose Amino Acids (HAA) n=5 Participants 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064	Bed Rest in Healthy Subjects, Physical Therapy (PT) n=6 Participants 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days Intensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB IRB 17-0064	Bed Rest in Type 2 Diabetes (T2DM), Physical Therapy (PT) n=6 Participants 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days Intensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB IRB 17-0064	Total n=50 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=37 Participants	1 Participants n=37 Participants	1 Participants n=74 Participants	1 Participants n=267 Participants	1 Participants n=272 Participants	0 Participants n=6 Participants	0 Participants n=36 Participants	6 Participants n=18 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=37 Participants	6 Participants n=37 Participants	4 Participants n=74 Participants	5 Participants n=267 Participants	4 Participants n=272 Participants	6 Participants n=6 Participants	6 Participants n=36 Participants	44 Participants n=18 Participants
Age, Continuous	68 years STANDARD_DEVIATION 4 • n=37 Participants	67 years STANDARD_DEVIATION 7 • n=37 Participants	73 years STANDARD_DEVIATION 6 • n=74 Participants	70 years STANDARD_DEVIATION 5 • n=267 Participants	71 years STANDARD_DEVIATION 8 • n=272 Participants	64 years STANDARD_DEVIATION 1 • n=6 Participants	68 years STANDARD_DEVIATION 6 • n=36 Participants	69 years STANDARD_DEVIATION 6 • n=18 Participants
Sex: Female, Male Female	5 Participants n=37 Participants	5 Participants n=37 Participants	2 Participants n=74 Participants	4 Participants n=267 Participants	3 Participants n=272 Participants	4 Participants n=6 Participants	4 Participants n=36 Participants	27 Participants n=18 Participants
Sex: Female, Male Male	10 Participants n=37 Participants	2 Participants n=37 Participants	3 Participants n=74 Participants	2 Participants n=267 Participants	2 Participants n=272 Participants	2 Participants n=6 Participants	2 Participants n=36 Participants	23 Participants n=18 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=267 Participants	0 Participants n=272 Participants	0 Participants n=6 Participants	0 Participants n=36 Participants	0 Participants n=18 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=267 Participants	0 Participants n=272 Participants	0 Participants n=6 Participants	0 Participants n=36 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Asian	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=267 Participants	0 Participants n=272 Participants	0 Participants n=6 Participants	0 Participants n=36 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=267 Participants	0 Participants n=272 Participants	0 Participants n=6 Participants	0 Participants n=36 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Black or African American	1 Participants n=37 Participants	1 Participants n=37 Participants	1 Participants n=74 Participants	0 Participants n=267 Participants	1 Participants n=272 Participants	0 Participants n=6 Participants	1 Participants n=36 Participants	5 Participants n=18 Participants
Race (NIH/OMB) White	14 Participants n=37 Participants	6 Participants n=37 Participants	4 Participants n=74 Participants	6 Participants n=267 Participants	4 Participants n=272 Participants	6 Participants n=6 Participants	5 Participants n=36 Participants	45 Participants n=18 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=267 Participants	0 Participants n=272 Participants	0 Participants n=6 Participants	0 Participants n=36 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=267 Participants	0 Participants n=272 Participants	0 Participants n=6 Participants	0 Participants n=36 Participants	0 Participants n=18 Participants
Region of Enrollment United States	15 participants n=37 Participants	7 participants n=37 Participants	5 participants n=74 Participants	6 participants n=267 Participants	5 participants n=272 Participants	6 participants n=6 Participants	6 participants n=36 Participants	50 participants n=18 Participants

PRIMARY outcome

Timeframe: Change from baseline to up to 3 months

Measurement of change in leg lean mass by DEXA

Outcome measures

Outcome measures
Measure	Bed Rest in Type 2 Diabetes (T2DM), High-dose Amino Acids (HAA) n=5 Participants 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064	Resistance Training in Type 2 Diabetes (T2DM) n=15 Participants 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. Resistance exercise training: Supervised resistance exercise training, 3 times a week for 3 months	Bed Rest in Healthy Subjects, Low-dose Amino Acids (LAA) n=7 Participants 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064	Bed Rest in Healthy Subjects, High-dose Amino Acids (HAA) n=5 Participants 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064	Bed Rest in Type 2 Diabetes (T2DM), Low-dose Amino Acids (LAA) n=6 Participants 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064	Bed Rest in Healthy Subjects, Physical Therapy (PT) n=6 Participants 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days Intensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB IRB 17-0064	Bed Rest in Type 2 Diabetes (T2DM), Physical Therapy (PT) n=6 Participants 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days Intensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB 17-0064
Leg Lean Mass	-0.66 kg Standard Deviation 0.31	0.35 kg Standard Deviation 0.74	-0.55 kg Standard Deviation 0.42	-0.80 kg Standard Deviation 0.44	-0.44 kg Standard Deviation 0.32	-0.59 kg Standard Deviation 0.73	-0.40 kg Standard Deviation 0.34

SECONDARY outcome

Timeframe: Change from baseline to up to 3 months

Measurement of change in maximum strength by standard method

Outcome measures

Outcome measures
Measure	Bed Rest in Type 2 Diabetes (T2DM), High-dose Amino Acids (HAA) n=5 Participants 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064	Resistance Training in Type 2 Diabetes (T2DM) n=15 Participants 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. Resistance exercise training: Supervised resistance exercise training, 3 times a week for 3 months	Bed Rest in Healthy Subjects, Low-dose Amino Acids (LAA) n=7 Participants 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064	Bed Rest in Healthy Subjects, High-dose Amino Acids (HAA) n=5 Participants 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064	Bed Rest in Type 2 Diabetes (T2DM), Low-dose Amino Acids (LAA) n=6 Participants 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064	Bed Rest in Healthy Subjects, Physical Therapy (PT) n=6 Participants 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days Intensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB IRB 17-0064	Bed Rest in Type 2 Diabetes (T2DM), Physical Therapy (PT) n=6 Participants 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. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days Intensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB 17-0064
Knee Extension Strength	-30 Nm Standard Deviation 14	3 Nm Standard Deviation 11	-12 Nm Standard Deviation 20	-24 Nm Standard Deviation 16	-23 Nm Standard Deviation 13	-14 Nm Standard Deviation 9	-8 Nm Standard Deviation 22

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to up to 3 months

Measurement of change in amino acid transporter expression

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to up to 3 months

Measurement of change in muscle protein synthesis by standard stable isotope methodology