Mechanism of Insulin-Resistant in Lean Non-Diabetics

Phase 1

Completed

• Conditions: Type 2 Diabetes; Insulin Sensitivity; Insulin Resistance
• Interventions: Behavioral: exercise; Behavioral: Non exercise

• Registration Number: NCT00970099
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2007-03
• Study First Submitted: 2009-08-31
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Study Completion: 2009-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-22
• Last Update Posted: 2014-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	exercise	12 week exercise regimen
non-exercise	Non exercise	Normal lifestyle routine with no exercise for 12 weeks.

Primary Outcome Measures

Name	Time	Method
insulin sensitivity and insulin signaling	12 weeks

Trial Locations

Locations (1)

Ucsf Gcrc; 🇺🇸 San Francisco, California, United States