Status:
COMPLETED
Insulin and the Polycystic Ovary Syndrome--Weight Reduction Study
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Polycystic Ovary Syndrome
Obesity
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
The polycystic ovary syndrome is the leading cause of female infertility in the United States. The disorder affects approximately 6-10% of women of reproductive age. It is widely accepted that "insuli...
Detailed Description
Insulin resistance is present in women with PCOS. Women with PCOS are at high risk for developing type 2 diabetes, presumably due to the insulin resistance that accompanies the syndrome. Some actions ...
Eligibility Criteria
Inclusion
- Obese (≥ 30 kg/m2) premenopausal women with PCOS and normal women between 18-40 years of age.
- PCOS women only:
- oligomenorrhea (\<= 8 menstrual periods annually),
- biochemical hyperandrogenemia (elevated total or free testosterone),
- normal thyroid function tests and serum prolactin, and
- exclusion of 21alpha-hydroxylase deficiency by a fasting 17alpha-hydroxyprogesterone \<200 ng/dl.
- Normal women only:
- regular monthly menses, and
- normal serum total and free testosterone.
- All women:
- acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (CBC, SMA20, urinalysis),
- have not been dieting in the 3 months prior to study enrollment,
- signed, witnessed informed consent,
- ability to comply with study requirements.
Exclusion
- 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).
- Documented or suspected recent (within one year) history of drug abuse or alcoholism.
- Ingestion of any investigational drug within 3 months prior to study onset.
- Pregnancy as documented by urine hCG.
- PCOS women only: Change in PCOS medication regimen (oral contraceptives, spironolactone, insulin sensitizers) within 3 months prior to the start of the study.
- Normal women only:
- history of gestational diabetes,
- positive family history for first-degree relative with diabetes,
- disorders linked to insulin resistance (hypertension or dyslipidemia),
- Use of oral or other systemic contraceptives, or spironolactone within 3 months prior to the start of the study,
- Use of medications (including OTC drugs) known to affect insulin sensitivity such as metformin, rosiglitazone, pioglitazone, niacin, corticosteroids, beta blockers, calcium channel blockers and thiazide diuretics within 3 months prior to the start of the study.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00436865
Start Date
February 1 2007
End Date
December 1 2017
Last Update
March 30 2018
Active Locations (1)
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1
Virginia Commonwealth University General Clinical Research Center
Richmond, Virginia, United States, 23298