Effects of Metformin With or Without Folate Supplementation on Homocysteine Levels and Endothelium in Women With Polycystic Ovary Syndrome
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)
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Endothelial structure and function
Italy: The Italian Medicines Agency