Effect of Liraglutide on Different Parameters (Clinical , Metabolic and Hormonal) in Obese Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Body weight loss
研究概览
简要总结
The aim of this study is to compare the hormonal, metabolic and clinical effects of metformin and liraglutide in infertile women with PCOs.
详细描述
This prospective randomized clinical trial will be conducted at Gynecology and obstetrics department in Beni Suef University Hospital, Beni suef, Egypt.
The trial will be included 150 women with Poly cystic ovary syndrome based on the Rotterdam criteria.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged 18-45 years
- •Poly cystic ovary syndrome based on the Rotterdam criteria
排除标准
- •congenital adrenal hyperplasia,
- •poorly controlled thyroid disease
- •Taking antidiabetic drugs which can affect insulin resistance
- •chronic kidney disease
- •liver dysfunction (AST or ALT
- •Documented use of oral hormonal contraceptives and hormone-releasing implants
- •intolerance or allergy to liraglutide or metformin
研究组 & 干预措施
metformin
the patient is given Glucophage 1000 mg tab once daily after lunch for 6 months
干预措施: Metformin (Drug)
liraglutide
will receive the drug via daily subcutaneous injection to ensure optimal tolerability, the dose was titrated upward weekly by increments of 0.6 mg (i.e., 1.2 mg/day in week 2, 1.8 mg/day in week 3, 2.4 mg/day in week 4) until reaching the target therapeutic dose of 3.0 mg/day for 6-month study duration.
干预措施: liraglutide (Drug)
control
not given any drug
结局指标
主要结局
Body weight loss
时间窗: 1 months
basal body weight - body weight reached after treatment
Insulin Resistance (HOMA-IR)
时间窗: 6-months
次要结局
未报告次要终点
研究者
Sara Abdallah Mohamed Salem
Associate Professor of Obstetrics and Gynaecology Faculty of medicine Beni-Suef University
Beni-Suef University