Status:
TERMINATED
Effects of Pioglitazone on Insulin and Glucose Metabolism in Women With Polycystic Ovary Syndrome (PCOS)
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief 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...
Detailed 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 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00868140
Start Date
February 1 2009
End Date
August 1 2011
Last Update
June 10 2016
Active Locations (2)
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1
Virginia Commonwealth University General Clinical Research Center
Richmond, Virginia, United States, 23298
2
Hospital de Clinical Caracas
Caracas, Venezuela, 1071