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Muscle Insulin Resistance in Aging (Mirage)

Muscle Insulin Resistance In Aging

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02230839
Enrollment
200
Registered
2014-09-03
Start date
2014-06-30
Completion date
2025-12-31
Last updated
2025-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Sarcopenia

Keywords

insulin resistance, muscle, health education, exercise

Brief summary

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.

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.

Interventions

BEHAVIORALExercise

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).

BEHAVIORALEnergy 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.

Sponsors

AdventHealth Translational Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Measure of intramyocellular lipidsVisit 3 ~22 hoursA 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

MeasureTime frameDescription
Measure of insulin sensitivityVisit 3 ~22 hoursInsulin 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

MeasureTime frameDescription
Measure muscle strength and powerVisit 2 (baseline) and 6 monthsMuscle 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026