search
Back to results

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

Primary Purpose

Polycystic Ovary Syndrome, Obesity

Status
Suspended
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Metformin
Magnesium
PUFA
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovary syndrome, Obesity, Metformin, Magnesium, Polyunsaturated fatty acids

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Gineco Obstetricia Centro Médico "La Raza"

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Metformin

Magnesium

PUFA omega 3

Arm Description

Metformin 850mg twice a day for six months

Magnesium chloride 250mg daily for six months

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

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
July 27, 2015
Last Updated
February 7, 2023
Sponsor
Coordinación de Investigación en Salud, Mexico
search

1. Study Identification

Unique Protocol Identification Number
NCT02521753
Brief Title
Omega 3 Polyunsaturated Fatty Acids (PUFA) or Magnesium in Obese Polycystic Ovary Syndrome Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Suspended
Why Stopped
Recruitment was no longer possible due to the SAR-Cov-2 contingency
Study Start Date
August 2015 (Actual)
Primary Completion Date
August 2020 (Actual)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
Polycystic Ovary Syndrome (PCOS)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Obesity
Keywords
Polycystic ovary syndrome, Obesity, Metformin, Magnesium, Polyunsaturated fatty acids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
The study is open label. No blindness for participant or investigator is used
Allocation
Randomized
Enrollment
123 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
Metformin 850mg twice a day for six months
Arm Title
Magnesium
Arm Type
Experimental
Arm Description
Magnesium chloride 250mg daily for six months
Arm Title
PUFA omega 3
Arm Type
Experimental
Arm Description
Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) 1.1mg daily for six months
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Glucophage
Intervention Description
Intervention also includes weight reduction diet and exercise therapy
Intervention Type
Dietary Supplement
Intervention Name(s)
Magnesium
Other Intervention Name(s)
Nature made magnesium
Intervention Description
Intervention also includes weight reduction diet and exercise therapy
Intervention Type
Dietary Supplement
Intervention Name(s)
PUFA
Other Intervention Name(s)
Omega 3
Intervention Description
Intervention also includes weight reduction diet and exercise therapy
Primary Outcome Measure Information:
Title
Metabolic profile
Description
Serum concentration of metabolic biomarkers (glucose, insulin, triglycerides, cholesterol, HDL, M and M/I value derived from a euglycemic clamp)
Time Frame
Six months after intervention
Secondary Outcome Measure Information:
Title
Hormonal profile
Description
Serum concentration of hormones [Testosterone, dehydroepiandrosterone sulphate (DHEAs), sex hormone-binding globulin (SHBG), free androgen index (FAI)]
Time Frame
Six months after intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mardia Guadalupe López Alarcón, MD, phD
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Gineco Obstetricia Centro Médico "La Raza"
City
Mexico City
State/Province
D.f.
ZIP/Postal Code
2990
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to share data

Learn more about this trial

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

We'll reach out to this number within 24 hrs