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

Not Applicable

Recruiting

• Conditions: Aging; Sedentary Behavior; Pre-diabetes; Type 2 Diabetes; Muscle Atrophy
• Interventions: Behavioral: Bed rest

• Registration Number: NCT03761446
• Lead Sponsor: AdventHealth Translational Research Institute

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.

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.

Study Timeline

• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-11-30
• Study First Posted: 2018-12-03
• Study Start: 2019-03-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Older adults with pre-diabetes or type 2 Diabetes	Bed rest	Male and female older adults between the ages 60-80 with pre-diabetes or type 2 diabetes
Older adults without pre-diabetes or Type 2 Diabetes	Bed rest	Male and female older adults between the ages 60-80 without pre-diabetes or type 2 diabetes

Primary Outcome Measures

Name	Time	Method
Mitochondrial Respiration	Pre and Post Bed Rest	Determined by high resolution respirometry in permeabilized muscle fiber bundles
Leg Lean Mass	Pre and Post Bed Rest and following 4 weeks of ambulatory recovery	Determined by DXA (dual energy x-ray absorptiometry)

Secondary Outcome Measures

Name	Time	Method
Insulin Sensitivity	Pre and Post Bed Rest	Determined by hyperinsulinemic euglycemic glucose clamp
Physical function	Pre and Post Bed Rest	Determined by short physical performance battery

Trial Locations

Locations (1)

Translational Research Institute for Metabolism and Diabetes; 🇺🇸 Orlando, Florida, United States