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Alpha Lipoic Acid and Polycystic Ovary Syndrome

NCT00505427 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2013-07-01

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Alpha Lipoic Acid

Sponsors & Collaborators

Principal Investigators

  • Umesh Masharani, MD · University of California, San Francisco

  • Ira Goldfine, MD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00505427 on ClinicalTrials.gov