Combined Insulin Sensitizers as Double-Weapon to Detonate PCOS-induced Vicious Circle
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Improvement of mensural pattern
研究概览
简要总结
PCOS is a common and complex disease affecting women of reproductive age. It is characterized by its complex pathological symptoms and mechanisms resulting in endocrine and metabolic dysfunction. PCOS is highly associated with various metabolic and endocrinal disorders. Metformin is mainly used for its glucose-lowering effects for treatment and prevention of type-2 diabetes mellitus (DM), gestational DM, and PCOS. Myo-inositol (MI) protects against MAFLD through reduction of hepatic accumulation of triglycerides.
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
- •Residence;
- •level of education & type of work;
- •Marital and fertility statuses, and if infertility was the main complaint;
- •Presence of risk factors as sedentary lifestyle;
- •Emotional stress and family history of PCOS;
- •Obesity-related medical disorders especially DM or MAFLD;
- •History of previous treatment for PCOS and its outcomes;
- •Menstrual pattern such as infrequent menstrual periods.
排除标准
- •Women had other manifestations of metabolic syndrome:
- •Cardiac manifestations of PCOS;
- •Maintained on other therapies or prepared for /received laparoscopic intervention for PCOS;
- •Receiving scheduled exercise, lipid-lowering therapies, or maintained on diabetogenic drugs for any other indications;
- •Had morbid obesity with body mass index (BMI) >35 kg/m2;
- •Causes other than PCOS for infertility, manifest DM, hepatic or pancreatic diseases.
研究组 & 干预措施
Met Group
干预措施: Metformin Hydrochloride (Drug)
MM Group
干预措施: Combination of Metformin hydrochloride and MI/DCI (Drug)
结局指标
主要结局
Improvement of mensural pattern
时间窗: 6 months
The Evaluation of the success rate of the applied regimens to gain mensural regular pattern in PCOS Women
次要结局
未报告次要终点
研究者
Walid Mohamed Elnagar
Assistant professor of gynecology
Zagazig University