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Muscle Lipid and Insulin Resistance in the Elderly (MIRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00765505
Recruitment Status : Completed
First Posted : October 3, 2008
Last Update Posted : February 6, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Erin E. Kershaw, M.D., University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE October 2, 2008
First Posted Date  ICMJE October 3, 2008
Last Update Posted Date February 6, 2018
Study Start Date  ICMJE July 2004
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2008)
Examine if exercise-induced improvements in insulin sensitivity are similar in normal weight and in obese older subjects. [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Muscle Lipid and Insulin Resistance in the Elderly
Official Title  ICMJE Muscle Lipid and Insulin Resistance in the Elderly
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Exercise Group
    Intervention: Behavioral: Exercise Group
  • Experimental: Health Education Group
    Intervention: Behavioral: Health Education Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2018)
92
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2008)
300
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00765505
Other Study ID Numbers  ICMJE 0405764
5R01AG021961 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erin E. Kershaw, M.D., University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Bret H. Goodpaster, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP