Muscle Insulin Resistance in Aging (Mirage)

AdventHealth Translational Research Institute

Status: Active, not recruiting

Conditions: Insulin Resistance; Sarcopenia

Treatments: Behavioral: Energy Restriction-Induced Weight Loss; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02230839

TRIMDFH 500423

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 65 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

Exercise training protocol

Experimental group

Treatment:

Behavioral: Exercise

Energy restriction-induced weight loss

Experimental group

Treatment:

Behavioral: Energy Restriction-Induced Weight Loss

Health Education

No Intervention group