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NCT00868140 · ClinicalTrials.gov registry record · NA
Effects of Pioglitazone on Insulin and Glucose Metabolism in Women With Polycystic Ovary Syndrome (PCOS)
A NA study, sponsored by Virginia Commonwealth University.
- Terminated
- Registry status
- NA
- Development phase
- 51
- Enrollment target
NCT00868140: Clinical Trial NA study, sponsored by Virginia Commonwealth University.
NCT00868140 is a NA study that was terminated before completion, run by Virginia Commonwealth University. The registered enrollment target is 51 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00868140, a NA study, was terminated before completion, sponsored by Virginia Commonwealth University.
- TERMINATED
- Registry status
- NA
- Development phase
- 51 participants
- Enrollment target
Study Summary
Our hypothesis is that hyperinsulinemia increases the renal clearance of D-chiro-inositol (DCI) in women with polycystic ovary syndrome (PCOS) and that this leads to a reduction in circulating insulin-stimulated D-chiro-inositol-containing inositol phosphoglycan (DCI-IPG) release. To assess the effects of a chronic reduction in circulating insulin on DCI metabolism, we propose to reduce circulating insulin in obese women with PCOS by improving insulin sensitivity with the drug pioglitazone. Pioglitazone is a thiazolidinedione that improves peripheral insulin sensitivity, presumably by activation of the peroxisome proliferator-activated receptor gamma (PPARγ) receptor. Administration of pioglitazone to women with PCOS has been shown to improve insulin sensitivity, reduce insulin secretion, and decrease both fasting and post-prandial serum insulin concentrations.
Primary Outcome
Change in the Area Under the Curve DCI-IPG measurements in blood samples taken at 15 minute intervals during the 2 hour OGTT before treatment with pioglitazone or placebo. Values reported as a percentage of bioactivity measured at time 0. Negative values indicate a decrease relative to the time 0 measurement.
Interventions
- DRUG Placebo
- DRUG pioglitazone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2009-02 |
| Est. Completion | 2011-08 |
| Phase | NA |
Why NCT00868140 stopped before completion
NCT00868140 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00868140 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00868140 about?
NCT00868140 is a clinical study titled "Effects of Pioglitazone on Insulin and Glucose Metabolism in Women With Polycystic Ovary Syndrome (PCOS)". Our hypothesis is that hyperinsulinemia increases the renal clearance of D-chiro-inositol (DCI) in women with polycystic ovary syndrome (PCOS) and that this leads to a reduction in circulating insulin-stimulated D-chiro-inositol-containing inositol phosphoglycan (DCI-IPG) release. To assess the effe...
What is the current status of trial NCT00868140?
This trial is currently terminated. It is a NA study. The enrollment target is 51 participants. The study started on 2009-02. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00868140?
The interventions under investigation include: Placebo (DRUG), pioglitazone (DRUG).
Who is sponsoring clinical trial NCT00868140?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00868140's enrollment target sits among peer trials
51 1279th of 2000 higher than 722 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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