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It was not possible to continue recruiting due to SARSCov2 pandemia. Results obtained at that time were already published
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Polycystic ovary syndrome (PCOS) is the most prevalent endocrine disorder in reproductive age women. PCOS is usually characterized by an excessive androgen production, menstrual irregularities, and polycystic ovaries. Women with PCOS are often obese and have a varying degree of insulin resistance (IR). Weight reduction constitutes the initial treatment for these patients. Metformin has proven to be useful in IR and is frequently used in PCOS. However metformin use may be accompanied by gastrointestinal discomfort, and a high abandon rate. Other therapeutic alternatives such as magnesium and polyunsaturated fatty acids have been used in other IR states and may be useful in PCOS. The aim of this study is to asses the efficacy of these alternatives in obese PCOS patients.
Polycystic Ovary Syndrome (PCOS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Active Comparator | Metformin 850mg twice a day for six months |
|
| Magnesium | Experimental | Magnesium chloride 250mg daily for six months |
|
| PUFA omega 3 | Experimental | Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) 1.1mg daily for six months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Intervention also includes weight reduction diet and exercise therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic profile | Serum concentration of metabolic biomarkers (glucose, insulin, triglycerides, cholesterol, HDL, M and M/I value derived from a euglycemic clamp) | Six months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Hormonal profile | Serum concentration of hormones [Testosterone, dehydroepiandrosterone sulphate (DHEAs), sex hormone-binding globulin (SHBG), free androgen index (FAI)] | Six months after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mardia Guadalupe López Alarcón, MD, phD | Instituto Mexicano del Seguro Social | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Gineco Obstetricia Centro Médico "La Raza" | Mexico City | D.F. | 2990 | Mexico |
There is not a plan to share data
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D008274 | Magnesium |
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D008673 |
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The study is open label. No blindness for participant or investigator is used
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| Magnesium | Dietary Supplement | Intervention also includes weight reduction diet and exercise therapy |
|
|
| PUFA | Dietary Supplement | Intervention also includes weight reduction diet and exercise therapy |
|
|
| 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 |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |