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
Holkova, Beata; Yazbeck, Victor; Kmieciak, Maciej et al. (2017) A phase 1 study of bortezomib and romidepsin in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, indolent B-cell lymphoma, peripheral T-cell lymphoma, or cutaneous T-cell lymphoma. Leuk Lymphoma 58:1349-1357
Corey, Kathleen E; Vuppalanchi, Raj; Vos, Miriam et al. (2015) Improvement in liver histology is associated with reduction in dyslipidemia in children with nonalcoholic fatty liver disease. J Pediatr Gastroenterol Nutr 60:360-7
Eaton, J E; Juran, B D; Atkinson, E J et al. (2015) A comprehensive assessment of environmental exposures among 1000 North American patients with primary sclerosing cholangitis, with and without inflammatory bowel disease. Aliment Pharmacol Ther 41:980-90
Worthington Jr, Everett L; Berry, Jack W; Hook, Joshua N et al. (2015) Forgiveness-reconciliation and communication-conflict-resolution interventions versus retested controls in early married couples. J Couns Psychol 62:14-27
Holkova, Beata; Kmieciak, Maciej; Perkins, E Brent et al. (2014) Phase I trial of bortezomib (PS-341; NSC 681239) and ""nonhybrid"" (bolus) infusion schedule of alvocidib (flavopiridol; NSC 649890) in patients with recurrent or refractory indolent B-cell neoplasms. Clin Cancer Res 20:5652-62
Lo, D J; Farris, A B; Song, M et al. (2013) Inhibition of ?v?6 promotes acute renal allograft rejection in nonhuman primates. Am J Transplant 13:3085-93
Jones, Robert; Vuky, Jacqueline; Elliott, Tony et al. (2013) Phase II study to assess the efficacy, safety and tolerability of the mitotic spindle kinesin inhibitor AZD4877 in patients with recurrent advanced urothelial cancer. Invest New Drugs 31:1001-7
Al Hawaj, M A; Martin, E J; Venitz, J et al. (2013) Monitoring rFVIII prophylaxis dosing using global haemostasis assays. Haemophilia 19:409-14
Noureddin, Mazen; Yates, Katherine P; Vaughn, Ivana A et al. (2013) Clinical and histological determinants of nonalcoholic steatohepatitis and advanced fibrosis in elderly patients. Hepatology 58:1644-54
Lo, D J; Anderson, D J; Weaver, T A et al. (2013) Belatacept and sirolimus prolong nonhuman primate renal allograft survival without a requirement for memory T cell depletion. Am J Transplant 13:320-8

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