Alpha Lipoic Acid and Polycystic Ovary Syndrome

Completed · Phase 1

Conditions studied: Insulin Resistance, Oxidative Stress

In brief

The study will recruit 40 subjects with Polycystic Ovary Syndrome (PCOS) as defined by the NIH criteria. The subjects will be pre-screened for insulin sensitivity using fasting insulin and glucose levels and oral glucose tolerance test. The 20 most insulin resistant subjects will undergo measurements of in vivo insulin action by hyperinsulinemic, euglycemic clamp. Body composition will be measured by dual-energy X-ray absorptiometry (DEXA). Plasma lipids and markers of oxidative stress will be measured. They will then receive open label controlled release alpha lipoic acid (CRLA) at 800 mg twice daily for 16 weeks. After treatment hyperinsulinemic euglycemic clamps, DEXA, plasma lipids and markers of oxidative stress will be repeated. Hypotheses: LA will improve insulin sensitivity in PCOS subjects; LA will reduce oxidative stress, testosterone levels and improve cardiovascular risk factors.

Key facts

Study ID

NCT00505427

Run by

University of California, San Francisco

People needed

22

Starts

2006-03-01

Expected to finish

2010-07-01

Last updated by the study team

2013-07-01

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• PCOS diagnosis
• 18 years of age or older
• Body Mass Index below 35
• Willing to use any form of contraception for the duration of the study

You may not qualify if…

• Diabetes
• Pregnancy
• Liver or heart disease or other health problems
• Taking medications that affect insulin resistance

Where it is running

• University of California at San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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