Omega 3 Polyunsaturated Fatty Acids (PUFA) or Magnesium in Obese Polycystic Ovary Syndrome Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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Polycystic Ovary Syndrome (PCOS)

Official Title
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Effect Polyunsaturated Fatty Acids or Magnesium in Metabolic, Hormonal, and Inflammatory Profile in Obese Women With Polycystic Ovary Syndrome. A Randomized Clinical Trial

Conditions
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Polycystic Ovary Syndrome, Obesity

Intervention / Treatment
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* Drug: Metformin
* Dietary Supplement: Magnesium
* Dietary Supplement: PUFA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Polycystic Ovary Syndrome according to Rotterdam criteria, BMI ≥ 27 Kg/m2 Exclusion Criteria: Type 2 diabetes mellitus, in treatment for polycystic ovary syndrome features

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin<br>Metformin 850mg twice a day for six months | Drug: Metformin<br>* Intervention also includes weight reduction diet and exercise therapy<br>* Other names: Glucophage;|
| Experimental: Magnesium<br>Magnesium chloride 250mg daily for six months | Dietary Supplement: Magnesium<br>* Intervention also includes weight reduction diet and exercise therapy<br>* Other names: Nature made magnesium;|
| Experimental: PUFA omega 3<br>Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) 1.1mg daily for six months | Dietary Supplement: PUFA<br>* Intervention also includes weight reduction diet and exercise therapy<br>* Other names: Omega 3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic ovary syndrome, Obesity, Metformin, Magnesium, Polyunsaturated fatty acids