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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| myo-inositol | Active Comparator | 1500 mg/day myoinositol |
|
| metformin | Active Comparator | 1500 mg/day of metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metformin 1500 mg | Drug |
| ||
| myoinositol 1500 mg |
| Measure | Description | Time Frame |
|---|---|---|
| number of cycles | six months |
| Measure | Description | Time Frame |
|---|---|---|
| effects of two therapies on glyco-insulinemic metabolism | Area under the curve insulin post oral glucose tolerance test (μUI/ML/180min), M value of euglycemic hyperinsulinaemic clamp(mg/kg/min). | six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Sacred Heart | Rome | 00168 | Italy |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D007294 | Inositol |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D013402 |
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|
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| Sugar Alcohols |
| D000438 | Alcohols |
| D002241 | Carbohydrates |