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Muscle Insulin Resistance in Aging (Mirage)

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Translational Research Institute for Metabolism and Diabetes, Florida
Sponsor:
Information provided by (Responsible Party):
Translational Research Institute for Metabolism and Diabetes, Florida
ClinicalTrials.gov Identifier:
NCT02230839
First received: August 7, 2014
Last updated: January 12, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Insulin Resistance Sarcopenia Behavioral: Exercise Behavioral: Energy Restriction-Induced Weight Loss

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Muscle Insulin Resistance In Aging

Resource links provided by NLM:


Further study details as provided by Translational Research Institute for Metabolism and Diabetes, Florida:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 Outcome Measures:
  • 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.



Estimated Enrollment: 200
Study Start Date: June 2014
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   65 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02230839

Contacts
Contact: Patty Ford 4073037100 tri@flhosp.org

Locations
United States, Florida
Translational Research Institute for Metabolism and Diabetes Recruiting
Orlando, Florida, United States, 32804
Contact: Patty Ford    407-303-7100      
Sub-Investigator: Steven Smith, MD         
Sub-Investigator: Richard Pratley, MD         
Sub-Investigator: Paul Coen, PhD         
Sponsors and Collaborators
Translational Research Institute for Metabolism and Diabetes, Florida
Investigators
Principal Investigator: Bret Goodpaster, PhD Translational Research Institute for Metabolism and Diabetes
  More Information

Additional Information:
Publications:

Responsible Party: Translational Research Institute for Metabolism and Diabetes, Florida
ClinicalTrials.gov Identifier: NCT02230839     History of Changes
Obsolete Identifiers: NCT01808924
Other Study ID Numbers: TRIMDFH 500423
Study First Received: August 7, 2014
Last Updated: January 12, 2017

Keywords provided by Translational Research Institute for Metabolism and Diabetes, Florida:
insulin resistance
muscle
health education
exercise

Additional relevant MeSH terms:
Insulin Resistance
Sarcopenia
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017