Identifying Therapeutic Targets of Accelerated Sarcopenia

NCT03118050 | Completed Results

• 2 other identifiers: 15-0229/17-0064R01AG049611
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sarcopenia; Diabetes Mellitus; Aging

Keywords

exercise; bed rest; muscle; nutrition; amino acids

Outcome Measures

Primary Outcomes (1)

• Leg Lean Mass

  Measurement of change in leg lean mass by DEXA

  Change from baseline to up to 3 months

Secondary Outcomes (1)

• Knee Extension Strength

  Change from baseline to up to 3 months

Other Outcomes (2)

• Amino Acid Transporter Expression

  Change from baseline to up to 3 months

• Muscle Protein Synthesis

  Change from baseline to up to 3 months

Study Arms (7)

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.

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.

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.

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.

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.

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.

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.

Behavioral: Bed rest; Behavioral: Intensive physical therapy

Interventions

Resistance exercise training BEHAVIORAL

Supervised resistance exercise training, 3 times a week for 3 months

Also known as: RT

RT in T2DM

Bed rest BEHAVIORAL

Bed rest for 5 days, followed by standard rehabilitation for 2 days

Also known as: BR

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 therapy BEHAVIORAL

Intensive weight bearing PT, daily, during bed rest

Also known as: PT

BR in T2DM, PT; BR in healthy subjects, PT

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Sealy Center on Aging, University of Texas Medical Branch

Galveston, Texas, 77550, United States

Location

MeSH Terms

Conditions

Sarcopenia; Diabetes Mellitus; Motor Activity

Interventions

Resistance Training; Bed Rest

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Elena Volpi, MD, PhD
• Organization: University of Texas Medical Branch

volpi@uthscsa.edu

210-562-6139

Study Officials

• Elena Volpi, MD, PhD

  UTMB

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: April 18, 2017
• Study Start: May 28, 2017
• Primary Completion: August 21, 2023
• Study Completion: August 21, 2023
• Last Updated: December 5, 2025
• Results First Posted: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)