Orlistat Versus Metformin induced Gut micro-organisms modification in Polycystic ovarian syndrome patients -A Randomized controlled study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Gut bacterial diversity before and after the treatment with metformin and orlistat in PCOS
研究概览
简要总结
PCOS being a heterogenous disorder with diverse features, obesity influences the phenotypic expression of PCOS, exacerbating metabolic, reproductive, and psychological features.
Weight loss reduces abdominal fat and insulin resistance and improves clinical features of PCOS.
Endotoxemia, a persistent inflammatory response, short-chain fatty acids and bile acid metabolism are all linked to the development of insulin resistance.
Moreover, people with PCOS have been found to have a major imbalance in their gut flora.
Reducing the insulin resistance and improving the gut flora, improves the various clinical features in PCOS
Orlistat helps to improve this heterogeneous symptoms of PCOS by altering abnormal gut microbiota to normal gut microbiota
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients diagnosed as PCOS according to ROTTERDAM CRITERIA With at least two of the following features : Oligo-amenorrhea or chronic anovulation Clinical and/or biochemical hyperandrogenism Ultrasound appearance of polycystic ovaries Able and willing to comply with the interventions and follow-up evaluations.
排除标准
- 未提供
结局指标
主要结局
Gut bacterial diversity before and after the treatment with metformin and orlistat in PCOS
时间窗: 3 months
次要结局
- Effects of Orlistat and Metformin in improvement of clinical and metabolic profile in PCOS patients
研究者
Divyabharathi
SRM university