A non – randomized control trial to study the effect of twenty percent calorie restriction vs metformin in elderly individuals above 65 years , with early diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change in Hba1c levels
研究概览
简要总结
a non randomized control trial to compare metformin with 20% calorie restriction , in elderly individuals > = 65yr , MNA SF score > 10
primary outcome to compare change in HbA1c level after three months
secondary outcome to compare change in HOMA - IR score and quality of life assessment
patient excluded if already taking any other anti diabetic drug , on drug that modify glucose metabolism like steroid
if any of the exclusion for metformin met , advanced kidney and renal disease, allergy to metformin or gastrointestinal side effects present to metformin then participants are added to calorie restriction group
2 weekly telephonic calls to confirm adherence to treatment or development of complications
100 sample size , 50 for metformin group and 50 for calorie restriction group
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 60.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •recruiting elderly above age of 60yr.
排除标准
- •Severe cognitive impairement Taking drugs interfering with glucose metabolism ( eg steroids Exclusion for metformin group : Patient with end stage renal disease (stage 4 , 5 Chronic liver disease (Child pugh B,C ) Allergy to metformin Severe gastrointestinal side effects to metformin.
结局指标
主要结局
change in Hba1c levels
时间窗: baseline , 13weeks
次要结局
- CHANGE IN HOMA -IR SCORE(CHANGE IN SF -36 SCORE)
研究者
dr kirti kamwani
AIIMS NEW DELHI