Metformin Plus EE30µg-drospirenone and Weight Loss- Impact on Endothelial Function and hsCRP Levels in PCOS
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- flow-mediated dilation
研究概览
简要总结
The purpose of this study is to assess the effects of ethinylestradiol 30µg-drospirenone combined with metformin and weight loss by means of dietary intervention on the indices of endothelial dysfunction (i.e. flow-mediated dilation and serum endothelin-1), serum hsCRP,lipids,insulin resistance and body composition in young women with PCOS.
详细描述
Women with polycystic ovary syndrome (PCOS) frequently cluster several cardiovascular risk markers and early subclinical atherosclerosis. Because combined oral contraceptives (COCs), the most common treatment of this disease, might adversely influence insulin resistance, glucose tolerance, lipid profile or aggravate chronic inflammation the possibility of worsening the already unfavorable cardiovascular risk profile of PCOS subjects is of concern. On the contrary, the insulin sensitizer metformin has been shown to ameliorate insulin resistance, reduce hyperandrogenism and triglyceride levels and also to improve endothelial structure and function in PCOS. Drospirenone (DRP) is a progestin with antiandrogenic and antimineralocorticoid activity. However, the studies assessing the effect of the COC containing 30 µg EE+3mg DRP (DRP/EE30µg) on surrogate markers of atherosclerosis are few and inconclusive. Therefore,the purpose of the present study is to assess the effects of the oral contraceptive DRP/EE30µg combined with metformin and weight loss by means of dietary intervention on the indices of endothelial dysfunction, i.e. flow-mediated dilation and serum endothelin-1, serum hsCRP,lipids, and insulin resistance in young women with PCOS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with diagnosis of polycystic ovary syndrome defined according to Androgen Excess Society 2006 guidelines
排除标准
- •secondary causes of hyperandrogenism such as hyperprolactinemia, thyroid disease, androgen-secreting tumours, Cushing's syndrome and congenital adrenal hyperplasia
- •current or previous use (within 6 months) of oral contraceptives, anti-androgens, ovulation induction medications
- •use of drugs known to affect carbohydrate-lipid metabolism or inflammation (anti-inflammatory drugs) at the time of evaluation and during the last one month preceding the evaluations
- •concurrent minor infection reported during the last one month preceding the evaluations
- •personal history of diabetes mellitus
研究组 & 干预措施
Metformin+Drospirenone / EE 30µg
干预措施: Metformin, Ethinylestradiol 30µg-Drospirenone (Drug)
结局指标
主要结局
flow-mediated dilation
时间窗: six months
次要结局
- endothelin-1(six months)
- hsCRP(six months)
- insulin resistance indices(six months)
- body composition(six months)
- lipid profile(six months)
- total testosterone(six months)
- sex hormone-binding globulin(six months)
- systolic blood pressure and diastolic blood pressure(six months)
研究者
Carmen Georgescu
Associated Professor
Iuliu Hatieganu University of Medicine and Pharmacy