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Active, Not Recruiting

NCT Number: NCT02230839

Muscle Insulin Resistance in Aging (Mirage)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Insulin Resistance Adherence Interventions Atrophy Behavior Glucose Metabolism Disorders Health Behavior Health Education Hyperinsulinism Medication Adherence Metabolic Diseases Motor Activity Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Sarcopenia Signs and Symptoms Treatment Adherence and Compliance

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

About this study

Study Objectives:

  • 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.
  • To determine the effects of diet-induced weight loss with and without the addition of exercise on intramyocellular lipid profiles.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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).

Energy Restriction-Induced Weight Loss

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

AdventHealth Translational Research Institute

Other

Registry information

Official study title

Muscle Insulin Resistance In Aging

Important dates

Study start
2014
Primary completion
2023
Study completion
2025
First posted
Sep 3, 2014
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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