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

NCT03761446 | Recruiting DMC

• 1 other identifier: TRIMD 1330040
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Muscle Atrophy; Aging; Sedentary Behavior; Pre-diabetes

Outcome Measures

Primary Outcomes (2)

• Leg Lean Mass

  Determined by DXA (dual energy x-ray absorptiometry)

  Pre and Post Bed Rest and following 4 weeks of ambulatory recovery

• Mitochondrial Respiration

  Determined by high resolution respirometry in permeabilized muscle fiber bundles

  Pre and Post Bed Rest

Secondary Outcomes (2)

• Insulin Sensitivity

  Pre and Post Bed Rest

• Physical function

  Pre and Post Bed Rest

Study Arms (2)

Older adults with pre-diabetes or type 2 Diabetes

EXPERIMENTAL

Male and female older adults between the ages 60-80 with pre-diabetes or type 2 diabetes

Behavioral: Bed rest

Older adults without pre-diabetes or Type 2 Diabetes

EXPERIMENTAL

Male and female older adults between the ages 60-80 without pre-diabetes or type 2 diabetes

Behavioral: Bed rest

Interventions

Bed rest BEHAVIORAL

The participant will remain in bed rest for 10 complete days.

Older adults with pre-diabetes or type 2 Diabetes; Older adults without pre-diabetes or Type 2 Diabetes

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be male or female between the ages of 60 and 80 years of age.
• 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.
• 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
• 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.
• Participant must have renal function with an estimated glomerular filtration rate (eGFR) \> 45 ml/min/1.73m2 determined at screening.
• Participant's triglyceride level is \< 350 mg/dl and LDL cholesterol is ≤ 150 mg/dl at screening.
• 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.
• 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.
• 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.

You may not qualify if:

• Participant has type 1 Diabetes.
• BMI \> 40.0 kg/m2
• Participant is actively pursuing weight loss and/or lifestyle changes.
• Participant has a history of pressure ulcers.
• Participant has a stated history of Deep Vein Thrombosis (DVT), pulmonary embolism, or a known hypercoagulable condition, or other clotting or bleeding disorders.
• History of gastrointestinal or intracranial hemorrhage.
• History of stroke or cerebrovascular accident.
• Recent history of major trauma (within 3 months).
• Thrombocytopenia (of any cause) or hyperkalemia (K \> 5.0) on screening laboratory assay. May repeat lab value per PI discretion.
• Untreated or poorly controlled hypertension (SBP \> 150, DBP \> 95), or hypotension (SBP \<100 DBP \<60)
• Participant has a TSH greater than or equal to 10mIU/L.
• Participant has current infection (requiring prescription antimicrobial or antiviral medication, or hospitalization), or corticosteroid treatment (with the exception of inhaled or topical steroids) in the last 3 months prior to screening visit.
• Participant is currently taking anti-inflammatory medication or has anti-inflammatory medication in the 1 weeks prior to screening (including over the counter formulations; e.g. Aleve, Motrin, ibuprofen, naproxen).
• Participant has had surgery requiring \> 2 days of hospitalization in the last 1 month prior to screening visit.
• Participant has an active malignancy or autoimmune disease.

Sponsors & Collaborators

• AdventHealth Translational Research Institute: lead

Study Sites (1)

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Muscular Atrophy; Sedentary Behavior; Glucose Intolerance

Interventions

Bed Rest

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Paul Coen, PhD

  Translational Research Institute for Metabolism and Diabetes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Recruitment Department

CONTACT

407-303-7100; tri@flhosp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: December 3, 2018
• Study Start: March 18, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)