Insulin and the Polycystic Ovary Syndrome--Weight Reduction Study

Completed · Not applicable

Conditions studied: Polycystic Ovary Syndrome, Obesity

In brief

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 "insulin resistance" may be responsible for the infertility of this syndrome. Women are insulin resistant when their bodies do not respond to insulin's action to handle sugar as they normally should. Because of this insulin resistance, women with the polycystic ovary syndrome are also at high risk for developing type 2 diabetes. We have previously shown that D-chiro-inositol (DCI), a substance naturally found in our body that helps insulin's action, is lacking in women with the polycystic ovary syndrome. Not having enough DCI may lead to insulin resistance. The purpose of this study is to determine if weight loss helps to replenish the body with DCI and help to promote insulin's action.

Key facts

Study ID

NCT00436865

Run by

Virginia Commonwealth University

People needed

79

Starts

2007-02-01

Expected to finish

2017-12-01

Last updated by the study team

2018-03-30

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Virginia Commonwealth University General Clinical Research Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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