Muscle Insulin Resistance in Aging (Mirage)

Not Applicable

Active, not recruiting

• Conditions: Insulin Resistance; Sarcopenia
• Interventions: Behavioral: Exercise; Behavioral: Energy Restriction-Induced Weight Loss

• Registration Number: NCT02230839
• Lead Sponsor: AdventHealth Translational Research Institute

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-08-07
• Study First Submitted QC: 2014-08-29
• Study First Posted: 2014-09-03
• 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: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise training protocol	Exercise	-
Energy restriction-induced weight loss	Energy Restriction-Induced Weight Loss	-

Primary Outcome Measures

Name	Time	Method
Measure of intramyocellular lipids	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 Outcome Measures

Name	Time	Method
Measure of insulin sensitivity	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.

Trial Locations

Locations (1)

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