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Alpha Lipoic Acid and Polycystic Ovary Syndrome

Phase 1
18 Years
50 Years
Open (Enrolling)
Insulin Resistance, Oxidative Stress

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Trial Information

Alpha Lipoic Acid and Polycystic Ovary Syndrome

Insulin resistance commonly occurs in patients with Polycystic Ovary Syndrome (PCOS) and may
be responsible for many of the long term complications of PCOS. Patients with PCOS are at
increased risk for developing type 2 diabetes and the metabolic syndrome (hypertension,
dyslipidemia and cardiovascular disease). Data suggest that oxidative stress contributes to
insulin resistance and thus inhibitors of oxidative stress improve insulin action. Alpha
Lipoic Acid (LA) is synthesized in the liver and other tissues and is a key component of
several mitochondrial enzyme complexes responsible for oxidative glucose metabolism and
cellular energy production. When used pharmacologically, LA functions as a safe and
effective antioxidant, recycling vitamins C and E,elevating glutathione levels,and lowering
reactive oxygen species. Cell culture studies reveal that LA reverses the effects of
oxidative stress and improving insulin action. Preliminary clinical data indicate that
antioxidants may improve insulin resistance in PCOS patients. We propose, therefore, to
study LA's effects on insulin-stimulated glucose uptake (insulin clamp) in a well
characterized population of insulin resistant PCOS patients. Because these patients usually
present in the adolescent and teenage years, the development of safe, long-term, treatment
strategies are needed.

Inclusion Criteria:

- 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

Exclusion Criteria:

- Diabetes

- Pregnancy

- Liver or heart disease or other health problems

- Taking medications that affect insulin resistance

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Umesh Masharani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Institutional Review Board

Study ID:




Start Date:

March 2006

Completion Date:

June 2008

Related Keywords:

  • Insulin Resistance
  • Oxidative Stress
  • PCOS
  • polycystic ovary syndrome
  • polycystic ovarian syndrome
  • alpha lipoic acid
  • insulin resistance
  • oxidative stress
  • Insulin Resistance
  • Polycystic Ovary Syndrome



University of California at San Francisco San Francisco, California  94115