Alpha Lipoic Acid and Insulin Resistance

Study Overview
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Brief Summary
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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
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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.

Official Title
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Alpha Lipoic Acid and Insulin Resistance

Conditions
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Insulin Resistance

Intervention / Treatment
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* Dietary Supplement: Alpha Lipoic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, not exercising regularly Exclusion Criteria: Diabetes, Impaired glucose tolerance, Heart disease, Liver disease, HIV, abnormal TSH results, other abnormal lab values

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anti-Oxidant<br>Alpha Lipoic Acid | Dietary Supplement: Alpha Lipoic Acid<br>* Two 400 mg tablets of Alpha Lipic Acid are taken 3 times daily<br>|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Alpha Lipoic Acid<br>* Two 400 mg tablets of Alpha Lipic Acid are taken 3 times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Resistance |  | 0 months and 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Insulin resistance, healthy controls, anti oxidants