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

Not Applicable

Suspended

• Conditions: Polycystic Ovary Syndrome; Obesity
• Interventions: Dietary Supplement: Magnesium; Dietary Supplement: PUFA; Drug: Metformin

• Registration Number: NCT02521753
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

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.

Detailed Description

Polycystic Ovary Syndrome (PCOS)

Study Timeline

• Study First Submitted: 2015-07-27
• Study Start: 2015-08
• Study First Submitted QC: 2015-08-12
• Study First Posted: 2015-08-13
• Primary Completion: 2020-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 123

Inclusion Criteria

• Polycystic Ovary Syndrome according to Rotterdam criteria,
• BMI ≥ 27 Kg/m2

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Exclusion Criteria

• Type 2 diabetes mellitus,
• in treatment for polycystic ovary syndrome features

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium	Magnesium	Magnesium chloride 250mg daily for six months
PUFA omega 3	PUFA	Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) 1.1mg daily for six months
Metformin	Metformin	Metformin 850mg twice a day for six months

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Hospital de Gineco Obstetricia Centro Médico "La Raza"; 🇲🇽 Mexico City, D.f., Mexico