Alpha Lipoic Acid and Insulin Resistance

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT00845156

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance	Dietary Supplement: Alpha Lipoic Acid	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Alpha Lipoic Acid and Insulin Resistance

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Anti-Oxidant Alpha Lipoic Acid	Dietary Supplement: Alpha Lipoic Acid Two 400 mg tablets of Alpha Lipic Acid are taken 3 times daily
Placebo Comparator: Placebo Placebo	Dietary Supplement: Alpha Lipoic Acid Two 400 mg tablets of Alpha Lipic Acid are taken 3 times daily

Arm

Intervention/Treatment

Active Comparator: Anti-Oxidant

Alpha Lipoic Acid

Dietary Supplement: Alpha Lipoic Acid

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

Placebo Comparator: Placebo

Placebo

Dietary Supplement: Alpha Lipoic Acid

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

Outcome Measures

Primary Outcome Measures

Insulin Resistance [0 months and 4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy, not exercising regularly

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California at San Francisco	San Francisco	California	United States	94143

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator: Umesh Masharani, MD, University of California, San Francisco
Principal Investigator: Martha Kennedy, MD, University of California, San Francisco