Metformin and Folate Supplementation in Polycystic Ovary Syndrome (PCOS) Patients
NCT ID: NCT00953355
Last Updated: 2010-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2004-01-31
2007-05-31
Brief Summary
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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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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Folate
Folate plus metformin
Folate plus metformin
A six-month course of metformin (1700 mg daily) plus folic acid (400 microgram daily).
Placebo
Placebo plus metformin
Placebo plus metformin
A six-month course of metformin (1700 mg daily) plus placebo
Interventions
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Folate plus metformin
A six-month course of metformin (1700 mg daily) plus folic acid (400 microgram daily).
Placebo plus metformin
A six-month course of metformin (1700 mg daily) plus placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
35 Years
FEMALE
No
Sponsors
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University Magna Graecia
OTHER
Locations
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"Pugliese" Hospital
Catanzaro, , Italy
Countries
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References
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Palomba S, Falbo A, Giallauria F, Russo T, Tolino A, Zullo F, Colao A, Orio F. Effects of metformin with or without supplementation with folate on homocysteine levels and vascular endothelium of women with polycystic ovary syndrome. Diabetes Care. 2010 Feb;33(2):246-51. doi: 10.2337/dc09-1516. Epub 2009 Nov 23.
Other Identifiers
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07/009
Identifier Type: -
Identifier Source: org_study_id