Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
149 participants
INTERVENTIONAL
2004-02-29
2009-12-31
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Exercise
12 week exercise regimen
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
non-exercise
Normal lifestyle routine with no exercise for 12 weeks.
Non exercise
subjects randomized to this group will not undergo exercise training for 12 weeks supervised by exercise specialist
Interventions
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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
Non exercise
subjects randomized to this group will not undergo exercise training for 12 weeks supervised by exercise specialist
Eligibility Criteria
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Inclusion Criteria
* No regular exercise for past 2 years
Exclusion Criteria
* 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)
20 Years
50 Years
ALL
Yes
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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UCSF
Locations
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Ucsf Gcrc
San Francisco, California, United States
Countries
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Other Identifiers
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H6820-22194
Identifier Type: -
Identifier Source: org_study_id
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