Mechanism of Insulin-Resistant in Lean Non-Diabetics

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT00970099

Collaborator

(none)

149

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance Insulin Sensitivity Type 2 Diabetes	Behavioral: exercise Behavioral: Non exercise	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

149 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2004

Actual Primary Completion Date :

Mar 1, 2007

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Exercise 12 week exercise regimen	Behavioral: 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
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

Arm

Intervention/Treatment

Active Comparator: Exercise

12 week exercise regimen

Behavioral: 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

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

Outcome Measures

Primary Outcome Measures

insulin sensitivity and insulin signaling [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ucsf Gcrc	San Francisco	California	United States	94143

Sponsors and Collaborators

University of California, San Francisco

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00970099

Other Study ID Numbers:

H6820-22194
1R01DK059358-01A2

First Posted:

Sep 2, 2009

Last Update Posted:

Jan 23, 2014

Last Verified:

Jan 1, 2014

Additional relevant MeSH terms:

Insulin Resistance

Study Results

No Results Posted as of Jan 23, 2014