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NCT00505427 · ClinicalTrials.gov registry record · Phase 1
Alpha Lipoic Acid and Polycystic Ovary Syndrome
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT00505427 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 22 participants.
The verdict
NCT00505427, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
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.
Interventions
- DIETARY_SUPPLEMENT Alpha Lipoic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2006-03 |
| Est. Completion | 2010-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00505427
The ClinicalTrials.gov registry entry for NCT00505427 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Alpha Lipoic Acid is the first listed.
NCT00505427 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00505427 about?
NCT00505427 is a clinical study titled "Alpha Lipoic Acid and Polycystic Ovary Syndrome". 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 measurement...
What is the current status of trial NCT00505427?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2006-03. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00505427?
The interventions under investigation include: Alpha Lipoic Acid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00505427?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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