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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Polycystic Ovary Syndrome

In brief

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.

Key facts

Study ID

NCT00868140

Run by

Virginia Commonwealth University

People needed

51

Starts

2009-02-01

Expected to finish

2011-08-01

Last updated by the study team

2016-06-10

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Obese (Body Mass Index or 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,
• 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.

You may not qualify if…

• 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.

Where it is running

• Virginia Commonwealth University General Clinical Research Center — Richmond, Virginia, United States
• Hospital de Clinical Caracas — Caracas, Venezuela

Full record on ClinicalTrials.gov

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