Effects of Pioglitazone on Insulin and Glucose Metabolism in Women With Polycystic Ovary Syndrome (PCOS) (PCOS)
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|ClinicalTrials.gov Identifier: NCT00868140|
Recruitment Status : Terminated (Lack of recruitment)
First Posted : March 24, 2009
Results First Posted : June 10, 2016
Last Update Posted : June 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome||Drug: pioglitazone Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Determination if Indirectly Reducing Circulating Insulin by Improving Insulin Sensitivity With Pioglitazone Reduces Renal Clearance of D-chiro-inositol (DCI) Increases the Circulating Concentration of DCI and Enhances Insulin-stimulated Release of the D-chiro-inositol-containing Inositolphosphoglycan (DCI-IPG) Mediator in Obese Women With PCOS|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||August 2011|
Pioglitazone in pill form at 45mg twice per day for 6 months
pioglitazone 45 mg
Placebo Comparator: 2/Placebo
Placebo control to arm 1 in pill form identical to treatment form also twice per day for 6 months
- AUC DCI-IPG (%/Min) [ Time Frame: Baseline ]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.
- AUC DCI-IPG (%/Min) [ Time Frame: 6 months ]Change in the Area Under the Curve DCI-IPG measurements in blood samples taken at 15 minute intervals during the 2 hour OGTT following 6 months of 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.
- Fasting Serum Insulin [ Time Frame: baseline ]Fasting serum insulin (uIU.min/ml) measured at 0, 60 and 120 minutes of a 2 hour OGTT before treatment with either pioglitazone or placebo
- Fasting Serum Insulin (uIU/ml) [ Time Frame: 6 months ]Fasting serum insulin (uIU.min/ml) measured at 0, 60 and 120 minutes of a 2 hour OGTT following 6 months treatment with either pioglitazone or placebo
- Matsuda Index [ Time Frame: Baseline ]
Whole body insulin sensitivity as determined by the Matsuda Index as calculated using the following formula:
10,000 divided by the square root of (FPI* FPG) * (xGPC* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load.
Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher scores indicating better insulin sensitivity. A value of 2.5 or less is indicative of insulin resistance.
- Matsuda Index [ Time Frame: 6 months ]Whole body insulin sensitivity as determined by the Matsuda Index
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868140
|United States, Virginia|
|Virginia Commonwealth University General Clinical Research Center|
|Richmond, Virginia, United States, 23298|
|Hospital de Clinical Caracas|
|Caracas, Venezuela, 1071|
|Principal Investigator:||John E. Nestler, M.D.||Virginia Commonwealth University|