Short-term Liraglutide Treatment in Obese Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 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
The purpose of this study was to determine whether liraglutide is more effective than metformin in the treatment of obese women with newly diagnosed polycystic ovary syndrome (PCOS). We anticipated greater changes in body weight in patients treated with liraglutide than in those treated with metformin.
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
metformin
In the MET group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg BID per os.
干预措施: metformin (Drug)
liraglutide
In the LIRA group liraglutide was initiated at a dose of 0.6 mg injected sc once per day and increased to 1.2 mg/day after 1 week.
干预措施: 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 mesured at the base point and every four weeks during 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 every four weeks during the 12 weeks of clinical trial. Patient's height was measured at the basepoint.)
- The secondary outcome was change in waist circumference.(Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial.)
研究者
Andrej Janez
professor, MD, PhD
University Medical Centre Ljubljana