Muscle Insulin Resistance in Aging (Mirage)

August 1, 2025 updated by: AdventHealth Translational Research Institute

Muscle Insulin Resistance In Aging

The purpose of this study is to provide information regarding potential factors underlying metabolic dysfunction, insulin resistance, and loss of muscle mass in aging muscle.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Objectives:

  1. To determine the effects of diet-induced weight loss with and without the addition of exercise on mitochondrial biogenesis and energetic capacity, cellular redox state and insulin resistance.
  2. To determine the effects of diet-induced weight loss with and without the addition of exercise on intramyocellular lipid profiles.
  3. To determine the effects of diet-induced weight loss with and without exercise on skeletal muscle proteins mediating a program of autophagy and either loss or maintenance of muscle mass.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Translational Research Institute for Metabolism and Diabetes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 65-80 years of age
  • Stable weight (No Gain/Loss of >10 lbs in 6 months)
  • Sedentary (≤ 1 continuous exercise/week)
  • Non-smoker
  • BMI ≥ 30 kg/m2
  • Resting Blood Pressure ≤ 150 millimeters of mercury systolic and ≤ 95 millimeters of mercury diastolic
  • Note from Primary care physician/Cardiologist for exercise clearance if positive stress test symptoms were observed from exercise test
  • Must be willing to washout for 14 days from all diabetes medication and independent in self blood glucose monitoring during the washout periods (those with diabetes only)

Exclusion Criteria:

  • Clinically significant cardiovascular disease including history of myocardial infarction, within the past year
  • Peripheral Vascular Disease
  • Hepatic, renal, muscular/neuromuscular, or active hematologic/oncologic disease
  • Clinically diminished pulse
  • Presence of bruits in lower extremities
  • Previous history of pulmonary emboli
  • Peripheral Neuropathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise training protocol
Behavioral: Exercise
Participants will complete a progressive 6-month exercise training program, 4-5 days per week, 45 min per session (180 min per week), consisting mostly of walking (both outside and on an indoor treadmill) but with the option to include stationary cycling, elliptical and rowing machines, similar to what we have utilized previously to elicit significant improvements in insulin sensitivity in both middle-age and older adults (52-55). Beginning at week 8, these subjects will also perform 2 non-consecutive resistance exercise sessions per week, 30 min per session, focused on major muscle groups using resistance machines (total days of exercise will still be 4 to 5).
Experimental: Energy restriction-induced weight loss
Behavioral: Energy Restriction-Induced Weight Loss
The goal of the weight loss intervention will be to produce a weight loss of 10% body weight. A reduction of 500-1000 kcal/day - based on baseline weight -and low fat (<30% of calories from fat) diet will be used as part of the weight loss intervention.
No Intervention: Health Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of intramyocellular lipids
Time Frame: Visit 3 ~22 hours
A percutaneous muscle biopsy of the vastus lateralis will be obtained, and the intramyocellular lipids will be measured by high-performance liquid chromatography-tandem mass spectrometry.
Visit 3 ~22 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of insulin sensitivity
Time Frame: Visit 3 ~22 hours
Insulin sensitivity will be measured using an intravenous catheter (glucose clamps) that will be placed in the antecubital vein for subsequent insulin and glucose infusions and for stable isotope infusions. This will measure insulin-stimulated changes in insulin signaling proteins and metabolism.
Visit 3 ~22 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure muscle strength and power
Time Frame: Visit 2 (baseline) and 6 months

Muscle strength and power will be measured in participants who have successfully completed all screening procedures.

Measurement is obtained using a short physical performance battery, knee extension, and muscle power testing using a pneumatic-driven dynamometer.
Visit 2 (baseline) and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth Translational Research Institute

Investigators

  • Principal Investigator: Bret Goodpaster, PhD, Translational Research Institute for Metabolism and Diabetes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

December 31, 2023

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 7, 2014

First Submitted That Met QC Criteria

August 29, 2014

First Posted (Estimated)

September 3, 2014

Study Record Updates

Last Update Posted (Actual)

August 3, 2025

Last Update Submitted That Met QC Criteria

August 1, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIMDFH 500423

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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