Mechanism of Insulin-Resistant in Lean Non-Diabetics

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970099
• Other study ID #: H6820-22194
• Secondary ID: 1R01DK059358-01A
• Status: Completed
• Phase: Phase 1
• First received: August 31, 2009
• Last updated: January 22, 2014
• Start date: February 2004
• Est. completion date: December 2009

Study information

• Verified date: January 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: December 2009
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Ucsf Gcrc	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin sensitivity and insulin signaling		12 weeks	No