Mechanism of Insulin-Resistant in Lean Non-Diabetics

NCT ID: NCT00970099

Last Updated: 2014-01-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2009-12-31

Brief Summary

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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

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Conditions

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Insulin Resistance Insulin Sensitivity Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise

12 week exercise regimen

Group Type ACTIVE_COMPARATOR

exercise

Intervention Type BEHAVIORAL

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.

Group Type PLACEBO_COMPARATOR

Non exercise

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Non exercise

subjects randomized to this group will not undergo exercise training for 12 weeks supervised by exercise specialist

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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UCSF

Locations

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Ucsf Gcrc

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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1R01DK059358-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H6820-22194

Identifier Type: -

Identifier Source: org_study_id

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