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Clinical Trials/NCT00970099
NCT00970099
Completed
Phase 1

Mechanism of Exercise Training in Lean Insulin-Resistant Non-Diabetics

University of California, San Francisco1 site in 1 country149 target enrollmentFebruary 2004

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Insulin Resistance
Sponsor
University of California, San Francisco
Enrollment
149
Locations
1
Primary Endpoint
insulin sensitivity and insulin signaling
Status
Completed
Last Updated
12 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
February 2004
End Date
December 2009
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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)

Outcomes

Primary Outcomes

insulin sensitivity and insulin signaling

Time Frame: 12 weeks

Study Sites (1)

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