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The Role of Type 2 Diabetes on Skeletal Muscle Atrophy and Recovery Following Bed Rest in Older Adults

NCT03761446•AdventHealth Translational Research Institute

Summary

The goal of this study is to determine the impact of pre-diabetes and type 2 diabetes on muscle atrophy during a period of bed rest and recovery of muscle mass, strength, and physical function following bed rest.

Detailed Description

Older adults with type 2 diabetes experience an accelerated rate of sarcopenia, which is the deterioration in muscle mass, strength and physical performance. Periods of disuse caused by illness or hospitalization cause rapid loss of muscle mass and strength, which negatively impact physical function upon re-ambulation. The impact of type 2 diabetes on acute muscle atrophy and recovery from disuse is a critical issue that has not been investigated. The overall objectives of this study are to employ highly innovative methods in muscle biopsy specimens in order to decipher the temporal sequence by which mitochondrial dysfunction and lipotoxicity in older adults with pre-diabetes and type 2 diabetes impact atrophy and recovery of muscle mass, strength and physical function following bed rest. Older adults with and without pre-diabetes/type 2 diabetes will complete 10 days of strict bed rest followed by 4 weeks of ambulatory recovery. During bed rest muscle biopsies will be collected to determine mitochondrial function and lipid profile. During the recovery period the recovery of muscle mass, strength and physical function will be determined.

Eligibility

Age

60 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Participant must be male or female between the ages of 60 and 80 years of age.
•2. Participant has pre-diabetes or type 2 diabetes and is only taking DPP-4 inhibitors, Sulfonylureas and/or Metformin therapy (but not Insulin, injectable incretin mimeticsSGL2 inhibitors, and Thiazolidinedione's), and has an A1C \< 8.0.
•1. Pre-Diabetics are defined as having an HgbA1c of greater than or equal to 5.7% and less 6.5%, or a fasting glucose of greater than or equal to 100 mg/dl and less than 126 mg/dl or has a glucose of greater than or equal to 140 mg/dl and less than 200mg/dl at the 2 hour blood draw during OGTT
•2. The non-diabetic control group is defined as having an HgbA1c of less than 5.7%, a fasting glucose of less than 100 mg/dl and a glucose level less than 140 mg/dl at the 2hr blood draw during the OGTT.
•3. Participant must have renal function with an estimated glomerular filtration rate (eGFR) \> 45 ml/min/1.73m2 determined at screening.
•4. Participant's triglyceride level is \< 350 mg/dl and LDL cholesterol is ≤ 150 mg/dl at screening.
•5. Participants must be non-smokers. Non-smokers as defined by not smoking any tobacco or using nicotine-containing products and not using vape pens or vaporizers within 3 months prior to screening.
•6. Participant states willingness to follow protocol as described, including consumption of study product per protocol, the prescribed activity level and completing any forms needed throughout the study.
•7. Participant has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.

Exclusion Criteria

•1. Participant has type 1 Diabetes.
•2. BMI \> 40.0 kg/m2
•3. Participant is actively pursuing weight loss and/or lifestyle changes.
•4. Participant has a history of pressure ulcers.
•5. Participant has a stated history of Deep Vein Thrombosis (DVT), pulmonary embolism, or a known hypercoagulable condition, or other clotting or bleeding disorders.
•6. History of gastrointestinal or intracranial hemorrhage.
•7. History of stroke or cerebrovascular accident.
•8. Recent history of major trauma (within 3 months).
•9. Thrombocytopenia (of any cause) or hyperkalemia (K \> 5.0) on screening laboratory assay. May repeat lab value per PI discretion.
•10. Untreated or poorly controlled hypertension (SBP \> 150, DBP \> 95), or hypotension (SBP \<100 DBP \<60)
+24 more criteria

Locations (1)

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, United States

Key Dates

Start Date

March 18, 2019

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

March 13, 2025

Enrollment

ESTIMATED participants

Conditions

Type 2 DiabetesMuscle AtrophyAgingSedentary BehaviorPre-diabetes

Interventions

Bed rest

BEHAVIORAL

Contacts

Recruitment Department

CONTACT

407-303-7100 tri@flhosp.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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The Role of Type 2 Diabetes on Skeletal Muscle Atrophy and Recovery Following Bed Rest in Older Adults

Inclusion Criteria

Exclusion Criteria

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