A Randomised, Double-blind, Placebo-controlled Study of the Effect of Liraglutide in Polycystic Ovary Syndrome on Risk Markers of Vascular Thrombosis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Jens Faber
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- Change in Endogenous Thrombin Potential (ETP)
研究概览
简要总结
Polycystic ovary syndrome (PCOS) affects 5-10% of women in fertile age. PCOS is associated with metabolic syndrom, diabetes and and increased risk og cardiovascular disease.
The study investigates the effect af intervention with GLP-1-analog on risk markers of cardiovascular disease in women with PCOS.
70 women will be included in af RCT.
Hypothesis: GLP-1-analog treatment in women with PCOS (without diabetes) will result in a beneficial reduction in risk markers of vascular thrombosis and early cardiovascular disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •>18 years
- •premenopausal
- •BMI >25 og 25 and thereunder + insulin resistent
- •Exclusion Criteria (including):
- •actualt or intended pregnancy
- •inadeqvat contraception
- •hormonal contraception within 6 weeks
- •metfoomin, GLP-1-analog or DPP IV inhibitor within 3 months
- •medications affectiv hemostatic mechanisme
- •diabetes or other severe comorbidity
- •familar MEN
排除标准
- 未提供
研究组 & 干预措施
Active
Liraglutide s.c. 1,8mg daily for 26 weeks
干预措施: Liraglutide for 26 weeks (Drug)
Placebo
Placebo s.c. daily for 26 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Change in Endogenous Thrombin Potential (ETP)
时间窗: at time 0 and 26 weeks
Area under curve in a Thrombin Generation Test (TGT). Measurements every min for 10 min
次要结局
- Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1(at time 0 and 26 weeks)
研究者
Jens Faber
Professor, DSc, Senior Hospital Physician
Herlev Hospital