Overview

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

Status:
Terminated
Trial end date:
2011-08-01
Target enrollment:
0
Participant gender:
Female
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 (PPARĪ³) 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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Virginia Commonwealth University
Treatments:
Inositol phosphate glycan
Insulin
Pioglitazone
Criteria
Inclusion Criteria:

1. 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,

2. 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).

3. Signed, witnessed informed consent.

4. Ability to comply with study requirements.

Exclusion Criteria:

1. 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).

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.