Mechanism of Insulin-Resistant in Lean Non-Diabetics
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|ClinicalTrials.gov Identifier: NCT00970099|
Recruitment Status : Completed
First Posted : September 2, 2009
Last Update Posted : January 23, 2014
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Exercise
12 week exercise regimen
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
- insulin sensitivity and insulin signaling [ Time Frame: 12 weeks ]
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 ClinicalTrials.gov identifier (NCT number): NCT00970099
|United States, California|
|San Francisco, California, United States, 94143|