To study the efficacy of Cabergoline as an adjunct to Metformin in management of overweight & obese women with PCOS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Regularization of menses
研究概览
简要总结
Women with PCOS have menstrual irregularities, hyperandrogenism and elevated level of inflammatory markers such as CRP , interleukins (IL-6, 18) TNF alpha, WBC count, chronic inflammatory state is further exacerbated by factors such as obesity and hyperinsulinemia, elevated level of inflammatory markers and oxidative stress indicate endothelial cell damage , Metformin alone is not as effective as in combination with other insulin sensitizer in improving glycolipid parameters in obese PCOS, Cabergoline an antiangiogenic reduces inflammatory markers in patients with prolactinoma and endometriosis. Cabergoline improves insulin sensitivity, leads to weight reduction and normalizing menstrual irregularities and androgen level in PCOS patients. We aim to evaluate the effect of add on Cabergoline with standard metformin on hormonal profile and menstrual regulation in women with overweight/obese PCOS.
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
- 16.00 Year(s) 至 35.00 Year(s)(—)
- 性别
- Female
入选标准
- •Women diagnosed with PCOS by Rotterdam criteria, Age 16-35 years, BMI 23-35 kg/m2, Willing to participate in the study.
排除标准
- •Patients with other endocrine disorders such as Cushing’s Syndrome, acromegaly, pituitary adenoma, etc , Women planning pregnancy in next 6 months, Intolerability to cabergoline, Not willing to participate.
结局指标
主要结局
Regularization of menses
时间窗: 6 months
次要结局
- Reduction in serum inflammatory markers(1, 3, 6 months)
- Improvement in glycemic parameter(1, 3, 6 MONTHS)
研究者
Dr Garima Kachhawa
AIIMS, New Delhi
