TerminatedNot Applicable

Effects of Pioglitazone on Insulin and Glucose Metabolism in Women With Polycystic Ovary Syndrome (PCOS)

Stopped: Lack of recruitment

United States, Venezuela51 participantsStarted 2009-02

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

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Inclusion criteria

✓. Obese (Body Mass Index or BMI greater than or equal to 30 kg/m2) women with PCOS between 18-40 years of age:

Exclusion criteria

✕. acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (Complete Blood Chemistry or CBC, Comprehensive Metabolic Panel denoted SMA20, urinalysis, negative pregnancy test).
✕. Signed, witnessed informed consent.
✕. Ability to comply with study requirements.
✕. Diabetes mellitus by fasting glucose or oral glucose tolerance test (OGTT), or clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer).
✕. Current use of oral contraceptives.
✕. Documented or suspected recent (within one year) history of drug abuse or alcoholism.
✕. Ingestion of any investigational drug within two months prior to study onset.

What they're measuring

AUC DCI-IPG (%/Min)

Timeframe: Baseline

AUC DCI-IPG (%/Min)

Timeframe: 6 months

Fasting Serum Insulin

Timeframe: baseline

Fasting Serum Insulin (uIU/ml)

Timeframe: 6 months

Trial details

NCT IDNCT00868140

SponsorVirginia Commonwealth University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-06

Results submitted2016-02-19

View on ClinicalTrials.gov More Polycystic Ovary Syndrome trials