Mechanism of Insulin-Resistant in Lean Non-Diabetics

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.

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Key information

Conditions

Insulin Resistance Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Sensitivity Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ucsf Gcrc

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise

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

Behavioral

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

Primary outcomes

insulin sensitivity and insulin signaling

Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2007
Study completion: 2009
First posted: Sep 2, 2009
Registry last updated: Jan 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed