Metformin and Folate Supplementation in Polycystic Ovary Syndrome (PCOS) Patients

November 2, 2010 updated by: University Magna Graecia

Effects of Metformin With or Without Folate Supplementation on Homocysteine Levels and Endothelium in Women With Polycystic Ovary Syndrome

Context: Metformin administration in women with polycystic ovary syndrome (PCOS) improves hormonal and metabolic patterns with beneficial effects in terms of reproductive outcomes and intermediate cardiovascular disease risk factors. Furthermore, reduced folate and vitamin B12, and increased homocysteine (Hcy) levels have been found in type-2 diabetes mellitus patients treated with metformin.

Objective: To evaluate if metformin administration exerts any effects on Hcy levels, and if folate supplementation may improve endothelial structure and function in PCOS patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fifty patients affected by PCOS without additional metabolic or cardiovascular diseases grouped in two age- and body mass index-matched treatment arms.

Interventions: A six-month course of metformin (1700 mg daily) plus folic acid (400 microgram daily) (experimental group, n=25) or placebo (control group, n=25) supplementation.

In each patient were evaluated: Complete hormonal and metabolic patterns, serum Hcy, folate, vitamin B12, and endothelin-1 (ET-1) concentrations, brachial artery diameter at baseline (BAD-B) and after reactive hyperemia (BAD-RH), flow-mediated dilation (FMD), and intima-media thickness (IMT) on both common carotid arteries.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catanzaro, Italy
        • "Pugliese" Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • PCOS

Exclusion Criteria:

  • age <18 or >35 years
  • BMI >35 kg/m2
  • neoplastic, metabolic, hepatic, renal, and cardiovascular disorders
  • Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Folate
Folate plus metformin
Drug: Folate plus metformin
A six-month course of metformin (1700 mg daily) plus folic acid (400 microgram daily).
PLACEBO_COMPARATOR: Placebo
Placebo plus metformin
Drug: Placebo plus metformin
A six-month course of metformin (1700 mg daily) plus placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endothelial structure and function
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical outcome Metabolic outcome Endocrine outcome
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Magna Graecia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion (ACTUAL)

May 1, 2007

Study Registration Dates

First Submitted

August 5, 2009

First Submitted That Met QC Criteria

August 5, 2009

First Posted (ESTIMATE)

August 6, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 3, 2010

Last Update Submitted That Met QC Criteria

November 2, 2010

Last Verified

August 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07/009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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