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

Obesity Clinical Trial

— OMgObPCOS  

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02521753
• Other study ID #: R-2014-785-056
• Status: Suspended
• Phase: N/A
• Start date: August 2015
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Polycystic Ovary Syndrome (PCOS)

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 123
• Est. completion date: July 2024
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Metformin
Intervention also includes weight reduction diet and exercise therapy

Dietary Supplement:
• Magnesium
Intervention also includes weight reduction diet and exercise therapy
• PUFA
Intervention also includes weight reduction diet and exercise therapy

Locations

Country	Name	City	State
Mexico	Hospital de Gineco Obstetricia Centro Médico "La Raza"	Mexico City	D.f.

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hormonal profile	Serum concentration of hormones [Testosterone, dehydroepiandrosterone sulphate (DHEAs), sex hormone-binding globulin (SHBG), free androgen index (FAI)]	Six months after intervention