Overview

This trial is active, not recruiting.

Condition polycystic ovary syndrome
Treatments pioglitazone, placebo
Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date February 2009
End date June 2011
Trial size 66 participants
Trial identifier NCT00868140, GCRC0824, VCUIRB4480

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 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,

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose health services research
Arm
(Experimental)
Pioglitazone
pioglitazone
pioglitazone 45 mg
(Placebo Comparator)
control to arm 1
placebo
placebo daily

Primary Outcomes

Measure
DCI-IPG and DCI measurements in blood and urine
time frame: 2 years

Secondary Outcomes

Measure
Measurement of sex steroids
time frame: 2 years

Eligibility Criteria

Female participants from 18 years up to 40 years old.

Inclusion Criteria: 1. Obese (BMI greater than or equal to 30 kg/m2) women with PCOS between 18-40 years of age: - oligomenorrhea (less than 8 menstrual periods annually) - biochemical hyperandrogenemia (elevated total or free testosterone) - normal thyroid function tests and serum prolactin; AND - exclusion of 21a-hydroxylase deficiency by a fasting 17a-hydroxyprogesterone less than 200 ng/dl.51, 2. acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (CBC, SMA20, urinalysis, negative pregnancy test). 3. Signed, witnessed informed consent. 4. Ability to comply with study requirements. Exclusion Criteria: 1. Diabetes mellitus by fasting glucose or OGTT, or clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer). 2. Current use of oral contraceptives. 3. Documented or suspected recent (within one year) history of drug abuse or alcoholism. 4. Ingestion of any investigational drug within two months prior to study onset.

Additional Information

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
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).