Mechanism of Insulin-Resistant in Lean Non-Diabetics

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. Identifier: NCT00970099
Recruitment Status : Completed
First Posted : September 2, 2009
Last Update Posted : January 23, 2014
Information provided by:
University of California, San Francisco

August 31, 2009
September 2, 2009
January 23, 2014
February 2004
March 2007   (Final data collection date for primary outcome measure)
insulin sensitivity and insulin signaling [ Time Frame: 12 weeks ]
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Complete list of historical versions of study NCT00970099 on Archive Site
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Mechanism of Insulin-Resistant in Lean Non-Diabetics
Mechanism of Exercise Training in Lean Insulin-Resistant Non-Diabetics

The study is designed to test the following primary hypothesis:

  • Aerobic exercise training will improve insulin sensitivity in insulin resistant subjects through changes in the major cellular signaling pathways and and/or their regulators.

Accordingly, the proposed study is designed to accomplish the following specific aims:

  • Quantitate how exercise training improves insulin sensitivity and decreases cardiovascular risk factors in a general population of lean, nondiabetic, insulin resistant subjects. Effects on known cardiovascular risk factors including blood pressure and serum lipoproteins will be evaluated. Change in regional adiposity will also be measured
  • Determine the effects of a program of regular aerobic exercise on in the insulin receptor signaling pathway. Biopsies of vastus lateralis muscle from insulin resistant subjects will be obtained before and after a hyperinsulinemic glucose clamp. This procedure will take place in the untrained state and after exercise training. The investigators will measure changes in the insulin receptor and the activity of the major components of the intracellular insulin signaling pathway. The investigators will also look intracellular proteins that regulate this signaling pathway.
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Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Insulin Resistance
  • Insulin Sensitivity
  • Type 2 Diabetes
  • Behavioral: exercise
    Patients exercise under supervision on either a treadmill, Stair Master, or LifeCycle apparatus. Exercise frequency, duration, and intensity will be incrementally increased to minimize the risk of injury. During weeks 1-3, you will exercise for 30 minutes 3 days per week at 70- 80 % of your maximum heart rate (MHR); weeks 4-7 will consist of exercising for 40 minutes 4 days per week at 70-80% of your MHR; and weeks 7-12 will consist of exercising for 45 minutes 4 days per week at 80-85% MHR
  • Behavioral: Non exercise
    subjects randomized to this group will not undergo exercise training for 12 weeks supervised by exercise specialist
  • Active Comparator: Exercise
    12 week exercise regimen
    Intervention: Behavioral: exercise
  • Placebo Comparator: non-exercise
    Normal lifestyle routine with no exercise for 12 weeks.
    Intervention: Behavioral: Non exercise
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2009
March 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women aged 20-50
  • No regular exercise for past 2 years

Exclusion Criteria:

  • Diabetes, Cardiovascular disease, Pregnant or lactating females,BMI >27
  • Medications that may interfere with carbohydrate metabolism - glucocorticoids, adrenergic agonists, ACE inhibitors, alpha blockers, diuretics, beta blockers, oral contraceptives, HMG CoA reductase inhibitors
  • History of epilepsy, cancer, hepatitis, active infection, active Graves' disease, cystic fibrosis, sickle cell anemia, peripheral vascular disease, cerebrovascular disease, asthma
  • Any medical condition that in the opinion of the investigator will interfere with safe completion of the trial
  • Inability to give informed consent
  • Prior participation in a clinical trial that could potentially alter insulin sensitivity: e.g., use of new insulin sensitizers
  • HIV seropositive
  • Anemia (Hgb < 12 g/dl)
Sexes Eligible for Study: All
20 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
1R01DK059358-01A2 ( U.S. NIH Grant/Contract )
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Ira Goldfine, UCSF
University of California, San Francisco
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University of California, San Francisco
January 2014

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