Comparative Study of Incretin System in Three Ethnic Groups With Abnormal Glucose Tolerance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- change in blood insulin response to sitagliptin
研究概览
简要总结
This study is conducted to examine GLP-1, insulin resistance and insulin sensitivity portfolio in Malay, Chinese and Indian populations in Malaysia and to study the effect of DPPIV inhibitor in T2DM patients with different GLP-levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are newly diagnosed of T2DM according to World Health Organisation criteria) and do not receive any glucose-lowering drugs
- •Subjects with normal glucose tolerance test according to World Health Organisation criteria which is carried out immediately before inclusion in the study
- •Subjects who are willing to participate and sign the informed consent form
排除标准
- •Patients with pre-existing T2DM
- •Patients with family history of diabetes
- •Patients receiving glucose-lowering medications
- •Patients with anemia, abnormal serum creatinine level, macroalbuminuria, proliferative retinopathy, impaired liver function
研究组 & 干预措施
low GLP-1 arm
Subjects are required to take oral 100mg Sitagliptin (Januvia) daily before breakfast for 12 weeks. 100mg is the recommended treatment dose. During the treatment with Januvia, subjects are not allowed to take any other medications except metformin
干预措施: Sitagliptin (Drug)
normal GLP-1 arm
Subjects are required to take oral 100mg Sitagliptin ( Januvia) daily before breakfast for 12 weeks. 100mg is the recommended treatment dose. During the treatment with Januvia, subjects are not allowed to take any other medications except metformin
干预措施: Sitagliptin (Drug)
结局指标
主要结局
change in blood insulin response to sitagliptin
时间窗: pre-treatment of sitagliptin and post 12-week treatment of sitagliptin
change from blood insulin response at 12 weeks
change in blood glucose load response to sitagliptin
时间窗: pre-treatment of sitagliptin and post 12-week treatment of sitagliptin
change from blood glucose response at 12 weeks
次要结局
未报告次要终点
研究者
Chong Shiau Chin
Pharmacist
National University of Malaysia