Myo-inositol Versus Metformin in Obese Women With Polycystic Ovary Syndrome
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ClinicalTrials.gov Identifier: NCT01791647
Recruitment Status : Unknown
Verified February 2013 by Maurizio Guido, Catholic University of the Sacred Heart. Recruitment status was: Recruiting
First Posted : February 15, 2013
Last Update Posted : February 15, 2013
Catholic University of the Sacred Heart
Information provided by (Responsible Party):
Maurizio Guido, Catholic University of the Sacred Heart
The aim of this study is to compare the effects of six months treatment of two insulin-lowering therapies on the clinical and endocrine-metabolic parameters in obese women affected by polycystic ovary syndrome. The study group includes 40 patients, randomly allocated to subgroup A (metformin 1500 mg/day) and subgroup B (myo-inositol 1500 mg/day). The investigations include menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipid profile at baseline and after six months of treatment.
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Ages Eligible for Study:
18 Years to 35 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
women with Polycystic Ovary Syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003;
age 18-35 years.
significant liver or renal impairment;
other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs);
unstable mental illness;
diagnosis of diabetes mellitus or impaired glucose tolerance;
use of drugs able to interfere with gluco-insulinaemic metabolism for at least three months prior to entering the study.