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Muscle Lipid and Insulin Resistance in the Elderly (MIRA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00765505
First received: October 2, 2008
Last updated: March 25, 2009
Last verified: March 2009
History of Changes
  Purpose

This project will provide novel information concerning the ability of exercise to enhance the capacity for oxidative metabolism of fatty acids and improve insulin resistance in older adults who are at high risk for the development of type 2 diabetes. Ultimately this may help identify mechanisms and therapeutic targets implicated in skeletal muscle metabolic dysregulation. The proposed study is to conduct a randomized controlled exercise training intervention trial in older men and women. In addition, the response to exercise in these subjects will be compared to those of highly endurance-trained, age-matched athletes.


Condition Intervention
Obesity
 Behavioral: Exercise Group
Behavioral: Health Education Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Muscle Lipid and Insulin Resistance in the Elderly

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Insulin sensitivity and muscle fat content will be measured at the beginning and the end of the intervention to determine the effects of exercise on these measures. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Examine if exercise-induced improvements in insulin sensitivity are similar in normal weight and in obese older subjects. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: July 2004
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Exercise Group
 Behavioral: Exercise Group
Sixteen week intervention where subjects will be progressed to four days per week for 45 minutes per session, 180 minutes minimum per week, of moderate intensity supervised exercise.
Experimental: Health Education Group Behavioral: Health Education Group
Sixteen week intervention. This group will not receive specific exercise education or prescription but will be asked to participate in biweekly health education sessions

Detailed Description:

Hypothesis and Specific Aims:

  1. To determine whether aerobic exercise improves both skeletal muscle fat distribution and insulin sensitivity of older men and women. We will test two hypotheses.

    i. Physical exercise in older adults will decrease the amount of fat interspersed within muscle, specifically the fat between muscle groups (intermuscular adipose tissue) as well as decrease specific lipid metabolites within muscle cells, compared to controls.

    ii. Exercise-induced improvements in insulin sensitivity of older men and women will be related to the changes in muscle fat content independent of changes in total body fat or visceral abdominal adipose tissue.

  2. To determine whether increased capacity for oxidative fatty acid metabolism within muscle results in improved insulin sensitivity in older adults. We will test two hypotheses.

    i. Exercise training will increase the capacity of muscle to oxidize fatty acids assessed both in vitro and in vivo.

    ii. Improved capacity for oxidative fatty acid metabolism will predict improvements in insulin sensitivity.

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 60 - 70 years of age
  • No weight gain/loss of >10 lbs in 6 months
  • Sedentary (No more than 1 continuous exercise/week) or Highly trained (>5 exercise sessions/week for a duration of one year or more)
  • Non-Smoker
  • BMI 18-38.0
  • Resting blood pressure less than 150mmHg systolic/95 mmHg diastolic
  • Normal glucose tolerance: Fasting glucose < 100 mg/dl or 2 hour glucose from OGTT < 140 mg/dl or impaired glucose tolerance (fasting glucose > 100 mg/dl < 126 mg/dl or 2 hour glucose from OGTT > 140 mg/dl but less than 200 mg/dl
  • Note from PCP/Cardiologist for exercise clearance if positive stress test symptoms were observed from GXT

Exclusion Criteria:

  • Clinically significant CVD including h/o MI
  • 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
  • Currently not engaged in a regular program and have a V)2 max pre-training value > 55 ml/kg-fat free mass-min., indicative of moderate fitness OR currently engaged in regular program and having a V)2 max value < 55 ml/kg-fat free mass-min.
  • Anemia (Hematocrit < 34%)
  • Any contraindications to moderate exercise
  • Inability and/or willingness to comply with the protocol as written
  • Active alcohol or substance abuse (Past 5 years)
  • Total cholesterol > 300 mg/dL
  • Triglyceride > 350 mg/dL
  • ALT > 80, AST > 80, Alk Phos > 240
  • Proteinuria (defined as > 1+ on routine dipstick) hypothyroidism (sTSH>8)
  • Therapeutic Doses of Nicotinic Acid
  • Type 2 Diabetes: Fasting Glucose > 126 mg/dl or 2 hour glucose > 200 mg/dl
  • Oral Glucocorticoids
  • Females currently on hormone replacement therapy (HRT) less than 6 months
  • Claustrophobia
  • Previous difficulty with lidocaine or other local anesthetic

  • Stress test symptoms:

    • Positive ECG (>2mm ST segment depression) without PCP cardiologist permission to participate
    • Signs or symptoms of cardiovascular decomposition (hypotensive response to exercise
    • Onset of angina or angina like symptoms, shortness of breath, change in heart rhythm, signs of poor perfusion (light-headedness), tightness
    • Hypotension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765505

Contacts
Contact: Jennifer Gabany, CRNP-C, CCRC 412-578-9259 jmg115@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Bret H. Goodpaster, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Bret H. Goodpaster, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00765505     History of Changes
Other Study ID Numbers: 0405764, 5 R01 AG021961
Study First Received: October 2, 2008
Last Updated: March 25, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Insulin Resistance
Obesity
Exercise Training
Physical Activity

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013