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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02521753
Acronym
OMgObPCOS
Enrollment
123
Registered
2015-08-13
Start date
2015-08-31
Completion date
2025-03-31
Last updated
2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome, Obesity

Keywords

Polycystic ovary syndrome, Obesity, Metformin, Magnesium, Polyunsaturated fatty acids

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)

Interventions

DRUGMetformin

Intervention also includes weight reduction diet and exercise therapy

DIETARY_SUPPLEMENTMagnesium

Intervention also includes weight reduction diet and exercise therapy

DIETARY_SUPPLEMENTPUFA

Intervention also includes weight reduction diet and exercise therapy

Sponsors

Coordinación de Investigación en Salud, Mexico
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Metabolic profileSix months after interventionSerum concentration of metabolic biomarkers (glucose, insulin, triglycerides, cholesterol, HDL, M and M/I value derived from a euglycemic clamp)

Secondary

MeasureTime frameDescription
Hormonal profileSix months after interventionSerum concentration of hormones \[Testosterone, dehydroepiandrosterone sulphate (DHEAs), sex hormone-binding globulin (SHBG), free androgen index (FAI)\]

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026