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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Polycystic Ovary Syndrome, Anovulation

Intervention / Treatment
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* Drug: Folate plus metformin
* Drug: Placebo plus metformin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Folate<br>Folate plus metformin | Drug: Folate plus metformin<br>* A six-month course of metformin (1700 mg daily) plus folic acid (400 microgram daily).<br>|
| Placebo Comparator: Placebo<br>Placebo plus metformin | Drug: Placebo plus metformin<br>* A six-month course of metformin (1700 mg daily) plus placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial structure and function |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome Metabolic outcome Endocrine outcome |  | six months |