The Impact of metformin Vs moderate intensity exercise on Insulin resistance in women with PCOS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Effect on insulin resistance
研究概览
简要总结
This is a randomized control trial aimed to compare the effect of metformin and moderate intensity exercise on insulin resistance in patients with PCOS.
Women between 18-40 years of age who are overweight/obese shall be included for the study after considering the exclusion criteria.
At baseline, anthropometry, body composition, hormonal profile and metabolic parameters would be recorded and hyperinsulinemic-euglycemic clamp would be done
Thereafter the participants would be randomised into metformin and the exercise group.
A 2 week run in period shall be given to the participants to acclimatise to the exercise program and tolerance to metformin shall be assessed.
The patients shall be followed at 0, 2 and 4 months.
Compliance to the intervention shall be ensured with telephonic calls.
At 4 months, metabolic. hormonal profile shall be repeated along with hyperinsulinemic-euglycemic clamp to assess the change in insulin resistance.
12 Healthy, age and BMI matched controls will be taken and a hyperinsulinemic euglycemic clamp would be performed at baseline for comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •overweight/obese PCOS women based on Asian BMI classification.
排除标准
- •Diabetes Mellitus Bleeding Disorders Hepatic or renal insufficiency Acute Infection Chronic Disorders Use of oral contraceptives/ hormone replacement therapy/insulin sensitizers within the past six weeks PREGNANCY H/O CAD/CVA/VTE SMOKING.
结局指标
主要结局
Effect on insulin resistance
时间窗: 4 months
次要结局
- Alterations In Body Mass Index, HOMA -IR, Luteinizing hormone, Follicle stimulating hormone,Testosterone(4 Months)