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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00868140 |
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 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 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,
Condition | Intervention |
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Polycystic Ovary Syndrome |
Drug: pioglitazone Drug: Placebo |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment |
Official Title: | Determination if Indirectly Reducing Circulating Insulin by Improving Insulin Sensitivity With Pioglitazone, Decreases Renal Clearance of DCI, Increases the Circulating Concentration of DCI, and Enhances Insulin-Stimulated Release of the DCI-IPG Mediator in Obese Women With PCOS |
Estimated Enrollment: | 66 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Pioglitazone
|
Drug: pioglitazone
pioglitazone 45 mg
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2: Placebo Comparator
control to arm 1
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Drug: Placebo
placebo daily
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This protocol focuses on the hypothesis that a deficiency in a putative inositolphosphoglycan (IPG) mediator of insulin action, namely a D-chiro-inositol-containing IPG (DCI-IPG), contributes to the insulin resistance of some women with PCOS. Our interest in this area stems directly from our previous studies, which demonstrated that administration of the precursor, D-chiro-inositol (DCI), to both obese23 and lean24 women with PCOS improved glucose intolerance while reducing circulating insulin, and simultaneously improved ovulatory function and decreased serum androgens. These findings were recently confirmed in a large-scale study by an independent group.25 The findings of these three studies suggested that administration of DCI improved insulin sensitivity in PCOS, which then resulted in an improved hormonal and metabolic milieu.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Obese (BMI greater than or equal to 30 kg/m2) women with PCOS between 18-40 years of age:
Exclusion Criteria:
Contact: Terre Y. Williams | 804 828-2663 | tywillia@vcu.edu |
United States, Virginia | |
Virginia Commonwealth University General Clinical Research Center | Recruiting |
Richmond, Virginia, United States, 23298 | |
Contact: Terre Y. Williams 804-828-2663 tywillia@vcu.edu | |
Contact: Manar T. Nazmy 804 827-0171 mtnazmy@vcu.edu | |
Principal Investigator: John E. Nestler, M.D. | |
Venezuela | |
Hospital de Clinical Caracas | Recruiting |
Caracas, Venezuela, 1071 | |
Contact: Daniela Jakubowicz, M.D. 305 308 42 06 daniela.jak@gmail.com | |
Principal Investigator: Daniela Jakubowicz, M.D. |
Responsible Party: | Virginia Commonwealth University ( John E. Nestler, M.D. ) |
Study ID Numbers: | VCUIRB4480, GCRC0824 |
Study First Received: | March 22, 2009 |
Last Updated: | March 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00868140 History of Changes |
Health Authority: | United States: Federal Government |
Obesity Pioglitazone Gonadal Disorders Endocrine System Diseases Ovarian Diseases Cysts Polycystic Ovarian Syndrome |
Insulin Genital Diseases, Female Hypoglycemic Agents Polycystic Ovary Syndrome Endocrinopathy Ovarian Cysts |
Disease Pioglitazone Gonadal Disorders Physiological Effects of Drugs Endocrine System Diseases Ovarian Diseases Cysts Pharmacologic Actions |
Adnexal Diseases Genital Diseases, Female Neoplasms Hypoglycemic Agents Pathologic Processes Syndrome Polycystic Ovary Syndrome Ovarian Cysts |