Alpha Lipoic Acid and Insulin Resistance

NCT ID: NCT00845156

Last Updated: 2013-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-09-30

Brief Summary

Subjects will be screened with a 2 hour oral glucose tolerance test. After this screening visit, their insulin resistance will be measured. Subjects will then be given either alpha lipoic acid (antioxidant) or placebo for 6 weeks. The insulin resistance test will be repeated after the 6 weeks. We believe these studies will confirm the beneficial effect of alpha lipoic acid on insulin sensitivity.

Detailed Description

We propose to perform a placebo-controlled study of Alpha Lipoic Acid (LA) administration in a cohort of non-obese, non-diabetic, insulin resistant subjects. The insulin sensitivity of 180 subjects will be initially estimated by measuring fasting glucose and insulin levels (homeostasis model assessment) and oral glucose tolerance test (OGTT). The 60 most insulin resistant subjects will then be randomized to 6 weeks of therapy with either 600 mg three times a day of LA or placebo. To quantitate the ALA-induced improvements, euglycemic hyperinsulinemic clamps to evaluate insulin sensitivity, OGTT using deuterated glucose to evaluate glycolytic glucose disposal, and muscle biopsies to evaluate insulin signaling pathways, will be performed before and after treatment. We believe these studies will (1) confirm the beneficial effect of CR-ALA on insulin sensitivity; (2) further our understanding of the molecular mechanisms of LA action; and (3) because these insulin resistant subjects are at risk for the development of type 2 diabetes, the Metabolic Syndrome, and coronary artery disease (CAD), a demonstration of the beneficial effects of LA on insulin action could ultimately have important public health consequences.

Conditions

Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Anti-Oxidant

Alpha Lipoic Acid

Group Type: ACTIVE_COMPARATOR

Alpha Lipoic Acid

Intervention Type: DIETARY_SUPPLEMENT

Two 400 mg tablets of Alpha Lipic Acid are taken 3 times daily

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Alpha Lipoic Acid

Intervention Type: DIETARY_SUPPLEMENT

Two 400 mg tablets of Alpha Lipic Acid are taken 3 times daily

Interventions

Alpha Lipoic Acid

Two 400 mg tablets of Alpha Lipic Acid are taken 3 times daily

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Healthy, not exercising regularly

Exclusion Criteria

• Diabetes, Impaired glucose tolerance, Heart disease, Liver disease, HIV, abnormal TSH results, other abnormal lab values

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Umesh Masharani, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Martha Kennedy, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California at San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

H6820-30422

Identifier Type: -

Identifier Source: org_study_id