Effects of Metformin With or Without Folate Supplementation on Homocysteine Levels and Endothelium in Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Endothelial structure and function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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.
研究组 & 干预措施
Folate
Folate plus metformin
干预措施: Folate plus metformin (Drug)
Placebo
Placebo plus metformin
干预措施: Placebo plus metformin (Drug)
结局指标
主要结局
Endothelial structure and function
时间窗: six months
次要结局
- Clinical outcome Metabolic outcome Endocrine outcome(six months)