An attempt to determine whether the combination of d-chiroinositol (INS-1) and metformin, or when given alone, will effect insulin sensitivity, hormonal profiles, and muscle second messengers in women with polycystic ovary syndrome. Polycystic ovary syndrome is associated with abnormal sex hormone production (high testosterone) and resistance to the hormone insulin. It has been found that abnormal sex hormone production in polycystic ovary syndrome can be improved by decreasing insulin levels with metformin. This study will hope to show that the two drugs given together will have an even better effect in lowering abnormal hormones. It will also determine if treatment with the two drugs will show changes in muscle tissue consistent with less resistance to insulin. 80 women with polycystic ovary syndrome will be enrolled in the study. Subjects will receive one medication, both, or a placebo for a total of eight weeks. Blood samples will be drawn on the first and the last days of the study. Insulin sensitivity tests will be done on the first and last days. This procedure involves simultaneously infusing insulin and glucose to maintain a normal blood sugar in the presence of high insulin in the blood. Frequent blood sampling will be done to assure a steady glucose level. The procedure will take place in the Clinical Research Center. At a designated point in the procedure, two muscle biopsies will be performed. A small piece of muscle tissue is removed from the thigh where no large blood vessels or nerves are located. A local anesthesia will be used. During the study, weekly visits to the Clinical Research Center will be made.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000065-38
Application #
6419246
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1977-12-01
Project End
2002-11-30
Budget Start
Budget End
Support Year
38
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Virginia Commonwealth University
Department
Type
DUNS #
City
Richmond
State
VA
Country
United States
Zip Code
23298
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