Alpha Lipoic Acid and Polycystic Ovary Syndrome

NCT00505427 | Completed Phase 1 DMC

• 1 other identifier: 8476-27691-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insulin Resistance; Oxidative Stress

Keywords

PCOS; polycystic ovary syndrome; polycystic ovarian syndrome; alpha lipoic acid; insulin resistance; oxidative stress

Interventions

Alpha Lipoic Acid DIETARY_SUPPLEMENT

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• PCOS diagnosis
• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of California at San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

• Masharani U, Gjerde C, Evans JL, Youngren JF, Goldfine ID. Effects of controlled-release alpha lipoic acid in lean, nondiabetic patients with polycystic ovary syndrome. J Diabetes Sci Technol. 2010 Mar 1;4(2):359-64. doi: 10.1177/193229681000400218.

  PMID: 20307398 DERIVED

MeSH Terms

Conditions

Insulin Resistance; Polycystic Ovary Syndrome

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Umesh Masharani, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Ira Goldfine, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2007
• First Posted: July 23, 2007
• Study Start: March 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 1, 2013

Record last verified: 2013-06

Locations

US (1)