Trial record 8 of 28 for:
nichd Polycystic Ovary Syndrome (PCOS)
Insulin and the Polycystic Ovary Syndrome--Weight Reduction Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was Recruiting
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First received: February 15, 2007
Last updated: July 31, 2007
Last verified: February 2007
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.
Polycystic Ovary Syndrome
Behavioral: Weight loss
Intervention Model: Parallel Assignment
Masking: Open Label
||Insulin and the Polycystic Ovary Syndrome
Primary Outcome Measures:
- Insulin sensitivity (Change from baseline to 8 weeks)
- Changes of Serum D-Chiro-Inositol (DCI) concentrations (Change from baseline to 8 weeks)
- Changes of DCI renal clearance (Change from baseline to 8 weeks)
- Changes of AUC insulin during OGTT (Change from baseline to 8 weeks)
- AUC of bioactive DCI-IPG during OGTT (Change from baseline to 8 weeks)
- Ratio of AUC DCI-IPG to AUC insulin during OGTT (Change from baseline to 8 weeks)
Secondary Outcome Measures:
- Weight loss (Change from baseline to 8 weeks)
- Serum Myo-Inositol (Myo) concentrations (Change from baseline to 8 weeks)
- MYO bioactivity (Change from baseline to 8 weeks)
- Serum inflammatory and cardiovascular markers (Change from baseline to 8 weeks)
| Estimated Enrollment:
| Study Start Date:
|Ages Eligible for Study:
||18 Years to 40 Years
|Genders Eligible for Study:
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436865
|Virginia Commonwealth University General Clinical Research Center
|Richmond, Virginia, United States, 23298 |
|Contact: Kai I. Cheang, Pharm.D. 804-828-9698 email@example.com |
|Principal Investigator: Kai I. Cheang, Pharm.D. |
||Kai I. Cheang, Pharm.D.
||Virginia Commonwealth University
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 15, 2007
||July 31, 2007
||United States: Federal Government
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 10, 2014
Polycystic Ovary Syndrome
Signs and Symptoms
Genital Diseases, Female
Endocrine System Diseases