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

Sponsor

Coordinación de Investigación en Salud, Mexico (Other)

Overall Status

Suspended

CT.gov ID

NCT02521753

Collaborator

(none)

123

Enrollment

Location

Arms

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome Obesity	Drug: Metformin Dietary Supplement: Magnesium Dietary Supplement: PUFA	N/A

Detailed Description

Polycystic Ovary Syndrome (PCOS)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

123 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

The study is open label. No blindness for participant or investigator is used

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Aug 1, 2020

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Metformin

Metformin 850mg twice a day for six months

Drug: Metformin

Intervention also includes weight reduction diet and exercise therapy

Other Names:

Glucophage

Experimental: Magnesium

Magnesium chloride 250mg daily for six months

Dietary Supplement: Magnesium

Intervention also includes weight reduction diet and exercise therapy

Other Names:

Nature made magnesium

Experimental: PUFA omega 3

Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) 1.1mg daily for six months

Dietary Supplement: PUFA

Intervention also includes weight reduction diet and exercise therapy

Other Names:

Omega 3

Outcome Measures

Primary Outcome Measures

Metabolic profile [Six months after intervention]
Serum concentration of metabolic biomarkers (glucose, insulin, triglycerides, cholesterol, HDL, M and M/I value derived from a euglycemic clamp)

Secondary Outcome Measures

Hormonal profile [Six months after intervention]
Serum concentration of hormones [Testosterone, dehydroepiandrosterone sulphate (DHEAs), sex hormone-binding globulin (SHBG), free androgen index (FAI)]