SarcopeniaNCT03118050
Identifying Therapeutic Targets of Accelerated Sarcopenia
A study testing Resistance exercise training, Bed rest and Intensive physical therapy in people with Sarcopenia and Diabetes Mellitus, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Diabetes Mellitus, Aging
- What is being tested?
- Resistance exercise training, Bed rest and Intensive physical therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2017to 21 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index: <40 kg/sq meter
- Score ≥26 on the 30-item Mini Mental State Examination
- Stable body weight for at least 3 months
- Non-diabetic or with Type 2 Diabetes Mellitus
Who cannot join
- Pre-diabetes per American Diabetes Association criteria
- Insulin therapy, significant diabetic complications, or A1c>8%
- Impairment in Activities of Daily Living
- >2 falls/year
- weight loss >5% in the past 6 months
- Exercise training (≥2 sessions/week) or ≥10,000 steps/day
Show all 10Show fewer
- Significant cardiovascular, liver, renal, blood, or respiratory disease
- Active cancer or infection
- Recent (within 3 months) treatment with anabolic steroids, systemic corticosteroids or estrogen.
- Alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Sealy Center on Aging, University of Texas Medical Branch
Galveston, Texas, 77550
About this study
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.
Read the detailed description
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.
- Conditions
- Sarcopenia, Diabetes Mellitus, Aging
- Being tested
- Resistance exercise training, Bed rest, Intensive physical therapy
- Keywords
- exercise, bed rest, muscle, nutrition, amino acids
- Medical subject headings
- Sarcopenia, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exercise trainingBehavioural
Also called RT
Supervised resistance exercise training, 3 times a week for 3 months
Bed restBehavioural
Also called BR
Bed rest for 5 days, followed by standard rehabilitation for 2 days
Intensive physical therapyBehavioural
Also called PT
Intensive weight bearing PT, daily, during bed rest
| Study group | Role | What they receive |
|---|---|---|
| RT in T2DM | Experimental | 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. Receives: Behavioral: Resistance exercise training |
| BR in healthy subjects, LAA | Experimental | 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. Receives: Behavioral: Bed rest |
| BR in healthy subjects, HAA | Experimental | 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. Receives: Behavioral: Bed rest |
| BR in T2DM, LAA | Experimental | 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. Receives: Behavioral: Bed rest |
| BR in T2DM, HAA | Experimental | 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. Receives: Behavioral: Bed rest |
| BR in healthy subjects, PT | Experimental | 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. Receives: Behavioral: Bed rest; Behavioral: Intensive physical therapy |
| BR in T2DM, PT | Experimental | 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. Receives: Behavioral: Bed rest; Behavioral: Intensive physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg Lean Mass
Measurement of change in leg lean mass by DEXA
Measured: Change from baseline to up to 3 months
Secondary outcomes (1)
Knee Extension Strength
Measurement of change in maximum strength by standard method
Measured: Change from baseline to up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start28 May 2017
- Primary completion21 Aug 2023
- Study completion21 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Elena Volpi, MD, PhD, Principal investigator, UTMB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118050
- Sponsor's protocol ID
- 15-0229/17-0064
- Other IDs
- R01AG049611
- Status last verified
- Nov 2025
- First submitted
- 8 Dec 2016
- Last updated
- 5 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Small physiological study. Few subjects. Risk of loss of confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Therapeutic Targets of Accelerated Sarcopenia
- ClinicalTrials.gov ID
- NCT03118050
- Acronym / sponsor ID
- 15-0229/17-0064
- Conditions
- Sarcopenia, Diabetes Mellitus, Aging
- Keywords
- exercise, bed rest, muscle, nutrition, amino acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 28 May 2017 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Posted 5 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| RT in T2DM | Experimental | Behavioral: Resistance exercise trainingType 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. |
| BR in healthy subjects, LAA | Experimental | Behavioral: Bed restHealthy 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. |
| BR in healthy subjects, HAA | Experimental | Behavioral: Bed restHealthy 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. |
| BR in T2DM, LAA | Experimental | Behavioral: Bed restType 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. |
| BR in T2DM, HAA | Experimental | Behavioral: Bed restType 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. |
| BR in healthy subjects, PT | Experimental | Behavioral: Bed rest, Behavioral: Intensive physical therapyHealthy 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. |
| BR in T2DM, PT | Experimental | Behavioral: Bed rest, Behavioral: Intensive physical therapyType 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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body mass index: <40 kg/sq meter
- Score ≥26 on the 30-item Mini Mental State Examination
- Stable body weight for at least 3 months
- Non-diabetic or with Type 2 Diabetes Mellitus
Key exclusion criteria (10 listed)
- Pre-diabetes per American Diabetes Association criteria
- Insulin therapy, significant diabetic complications, or A1c>8%
- Impairment in Activities of Daily Living
- >2 falls/year
- weight loss >5% in the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance exercise trainingAlso: RTSupervised resistance exercise training, 3 times a week for 3 months | Behavioural | RT in T2DM |
| Bed restAlso: BRBed rest for 5 days, followed by standard rehabilitation for 2 days | Behavioural | 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 |
| Intensive physical therapyAlso: PTIntensive weight bearing PT, daily, during bed rest | Behavioural | BR in T2DM, PT, BR in healthy subjects, PT |
Primary outcome
Leg Lean Mass
Time frame: Change from baseline to up to 3 months
Measurement of change in leg lean mass by DEXA
1 secondary outcome
Knee Extension Strength
Time frame: Change from baseline to up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Small physiological study. Few subjects. Risk of loss of confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Volpi, MD, PhD principal investigator
UTMB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise training, Bed rest and Intensive physical therapy in people with Sarcopenia and Diabetes Mellitus, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leg Lean Mass (time frame: Change from baseline to up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.