Low Dose Liraglutide and Metformin vs. High Dose Liraglutide Alone in Treatment of Obesity
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The main outcome was change in body weight.
研究概览
简要总结
Weight reduction is the most important treatment target when polycystic ovary syndrome (PCOS) is linked to obesity. Liraglutide (LIRA) in dose of 3 mg was recently approved as an anti-obesity drug. Metformin could enhance weight lowering potential of liraglutide.
We investigates short term interventions with low dose liraglutide in combination with metformin and high dose liraglutide alone influence on significant weight reduction in obese women with PCOS.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years old to menopause
- •polycystic ovary syndrome (NICHD criteria)
- •BMI of 30 kg/m² or higher
排除标准
- •type 1 or type 2 diabetes mellitus
- •history of carcinoma
- •Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
- •personal or family history of MEN 2
- •significant cardiovascular, kidney or hepatic disease
- •the use of medications known or suspected to affect reproductive or metabolic functions
- •the use of statins, within 90 days prior to study entry
研究组 & 干预措施
liraglutide
liraglutide 3 mg QD for 12 weeks
干预措施: liraglutide (Drug)
metformin and liraglutide
metformin 1000 mg BID and liraglutide 1.2 mg QD for 12 weeks
干预措施: metformin and liraglutide (Drug)
结局指标
主要结局
The main outcome was change in body weight.
时间窗: Patient's body weight was measured at the base point and after 12 weeks of clinical trial.
次要结局
- The secondary outcome was change in body mass index (BMI)(Patient's body weight were measured at the base point and after 12 weeks of clinical trial. Patient's height was measured at the base point.)
研究者
Andrej Janez
MD PhD
University Medical Centre Ljubljana