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Clinical Trials/NCT03761446
NCT03761446
Recruiting
Not Applicable

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

AdventHealth Translational Research Institute1 site in 1 country50 target enrollmentMarch 18, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
AdventHealth Translational Research Institute
Enrollment
50
Locations
1
Primary Endpoint
Mitochondrial Respiration
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 18, 2019
End Date
December 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
AdventHealth Translational Research Institute
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Mitochondrial Respiration

Time Frame: Pre and Post Bed Rest

Determined by high resolution respirometry in permeabilized muscle fiber bundles

Leg Lean Mass

Time Frame: Pre and Post Bed Rest and following 4 weeks of ambulatory recovery

Determined by DXA (dual energy x-ray absorptiometry)

Secondary Outcomes

  • Insulin Sensitivity(Pre and Post Bed Rest)
  • Physical function(Pre and Post Bed Rest)

Study Sites (1)

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