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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00436865 |
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.
Condition | Intervention |
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Polycystic Ovary Syndrome Obesity |
Behavioral: Weight loss |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Insulin and the Polycystic Ovary Syndrome |
Estimated Enrollment: | 104 |
Study Start Date: | February 2007 |
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Inclusion Criteria:
PCOS women only:
Normal women only:
All women:
Exclusion Criteria:
Normal women only:
Contact: Kai ("Annie") I Cheang, Pharm.D. | 804-828-9698 | kicheang@vcu.edu |
United States, Virginia | |
Virginia Commonwealth University General Clinical Research Center | Recruiting |
Richmond, Virginia, United States, 23298 | |
Contact: Kai I. Cheang, Pharm.D. 804-828-9698 kicheang@vcu.edu | |
Principal Investigator: Kai I. Cheang, Pharm.D. |
Principal Investigator: | Kai I. Cheang, Pharm.D. | Virginia Commonwealth University |
Study ID Numbers: | K23HD049454-01A2 |
Study First Received: | February 15, 2007 |
Last Updated: | July 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00436865 |
Health Authority: | United States: Federal Government |
Obesity Gonadal Disorders Endocrine System Diseases Overweight Ovarian Diseases Cysts Insulin Body Weight |
Genital Diseases, Female Signs and Symptoms Polycystic Ovary Syndrome Weight Loss Nutrition Disorders Overnutrition Endocrinopathy Ovarian Cysts |
Neoplasms Pathologic Processes Disease Syndrome Adnexal Diseases |