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Alpha Lipoic Acid and Polycystic Ovary Syndrome
This study is ongoing, but not recruiting participants.
First Received: July 20, 2007   Last Updated: June 11, 2008   History of Changes
Sponsors and Collaborators: University of California, San Francisco
National Institutes of Health (NIH)
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00505427
  Purpose

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.


Condition Intervention Phase
Insulin Resistance
Oxidative Stress
Dietary Supplement: Alpha Lipoic Acid
Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title: Alpha Lipoic Acid and Polycystic Ovary Syndrome

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Estimated Enrollment: 20
Study Start Date: March 2006
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00505427

Locations
United States, California
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: Ira Goldfine, MD University of California, San Francisco
  More Information

No publications provided

Study ID Numbers: 8476-27691-01
Study First Received: July 20, 2007
Last Updated: June 11, 2008
ClinicalTrials.gov Identifier: NCT00505427     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
PCOS
polycystic ovary syndrome
polycystic ovarian syndrome
alpha lipoic acid
insulin resistance
oxidative stress

Study placed in the following topic categories:
Antioxidants
Vitamin B Complex
Metabolic Diseases
Gonadal Disorders
Alpha-lipoic Acid
Stress
Endocrine System Diseases
Trace Elements
Ovarian Diseases
Cysts
Insulin
Polycystic Ovarian Syndrome
Genital Diseases, Female
Hyperinsulinism
Vitamins
Polycystic Ovary Syndrome
Micronutrients
Endocrinopathy
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Disorder
Ovarian Cysts
Thioctic Acid

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Physiological Effects of Drugs
Ovarian Diseases
Genital Diseases, Female
Hyperinsulinism
Pathologic Processes
Syndrome
Vitamins
Micronutrients
Metabolic Diseases
Disease
Vitamin B Complex
Growth Substances
Endocrine System Diseases
Cysts
Protective Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Polycystic Ovary Syndrome
Insulin Resistance
Glucose Metabolism Disorders
Ovarian Cysts
Thioctic Acid

ClinicalTrials.gov processed this record on September 11, 2009