The Hypoglycemic Effect of Cyclocarya Paliurus Extract on Hyperglycemic Populations
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- changes of HbA1c
研究概览
简要总结
This is a randomized double-blind controlled trial，aiming to investigate the hypoglycemic effect of Cyclocarya paliurus extract and Cyclocarya paliurus compounds on hyperglycemic populations without modifying their original treatment plans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The allocation of three groups is completed by the primary researcher,and unknown to participants and other reachers. It is the same in the size,color,shape and taste of capsules administrated by three groups.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pre-diabetic or type 2 diabetic patients who are treated with only one oral antidiabetic agent and whose fasting plasma glucose is lower than 8.4 mmol;
- •age:20-65 years;
- •BMI :20-35kg/m2.
排除标准
- •type 1 diabetic patients;
- •type 2 diabetic patients with insulin treatment；
- •pregnant or lactating women；
- •adverse effect on intervention；
- •acute or chronic inflammatory conditions;
- •severe hepatic,kidney or other complications;
- •other situations ineligible to intervention.
结局指标
主要结局
changes of HbA1c
时间窗: at 0 week，4th week and 12th week in the intervention period
glycated hemoglobin
changes of FPG
时间窗: at 0 week，4th week and 12th week in the intervention period
fasting plasma glucose
changes of fasting insulin
时间窗: at 0 week，4th week and 12th week in the intervention period
changes of OGTT
时间窗: at 0 week，4th week and 12th week in the intervention period
oral glucose tolerance test
次要结局
- changes of short chain fatty acids(at 0 week，4th week and 12th week in the intervention period)
- changes of blood lipids(at 0 week，4th week and 12th week in the intervention period)
- changes of gut microbiota(at 0 week，4th week and 12th week in the intervention period)
研究者
Liegang Liu
Professor
Huazhong University of Science and Technology