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

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Insulin Sensitivity Type 2 Diabetes Behavioral: exercise Behavioral: Non exercise Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mechanism of Exercise Training in Lean Insulin-Resistant Non-Diabetics
Study Start Date : February 2004
Actual Primary Completion Date : March 2007
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Exercise
12 week exercise regimen
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

Placebo Comparator: non-exercise
Normal lifestyle routine with no exercise for 12 weeks.
Behavioral: Non exercise
subjects randomized to this group will not undergo exercise training for 12 weeks supervised by exercise specialist

Primary Outcome Measures :
  1. insulin sensitivity and insulin signaling [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00970099

United States, California
Ucsf Gcrc
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco

Responsible Party: Ira Goldfine, UCSF Identifier: NCT00970099     History of Changes
Other Study ID Numbers: H6820-22194
1R01DK059358-01A2 ( U.S. NIH Grant/Contract )
First Posted: September 2, 2009    Key Record Dates
Last Update Posted: January 23, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases