Effect of Saxagliptin on Body Fat , Glucose and Beta Cell Function in Patients With Newly Diagnosed Pre-Diabetes Mellitus and Obesity
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- oral glucose tolerance test
研究概览
简要总结
The purpose of the study is to examine the effect of Saxagliptin in the newly diagnosed people with pre-diabetes and obesity besides lifestyle intervention ,there to evaluate DPP 4 inhibitors of reversing pre-diabetes curative effect to normal blood sugar, and observe its influences on the targets of obesity related metabolic abnormalities, to explore new ways for intervention on populations with pre-diabetes and obesity .
详细描述
Materials and Methods
This is a perspectiveness ,randomized, opening study, patients will be randomly assigned to the standarddose Saxagliptin group ,the lifestyle intervention group,the Metformin group and the low dose Saxagliptin group with a 6-month treatment period.
Oral glucose tolerance test will examined before and 6 months post-treatment during the trial.
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Newly diagnosed insulin resistance or glucose intolerance .
- •2.20 to 70 years of age.
- •3.BMI≥28kg/m2，or BMI>25kg/m2 beside waistline≥80cm（female)，≥90cm(male).
排除标准
- •Under Diabetes Mellitus treatment.
- •Allergy to dipeptidyl peptidase 4 (DPP-4) inhibitors .
- •Active heart failure.
- •Unwilling or unable to sign inform consents.
研究组 & 干预措施
Standarddose Saxagliptin
Saxagliptin 5 mg (tablet) ,5mg a day and lifestyle intervention for 6 months
干预措施: saxagliptin (Drug)
Lifestyle intervention
Lifestyle intervention for 6 months
干预措施: lifestyle intervention (Other)
Metformin
Metformin 500 mg (tablet) ,500mg three times a day and lifestyle intervention for 6 months
干预措施: metformin (Drug)
low dose Saxagliptin
Saxagliptin 5 mg (tablet) ,2.5 mg a day and lifestyle intervention for 6 months
干预措施: saxagliptin (Drug)
结局指标
主要结局
oral glucose tolerance test
时间窗: Change of Blood sugar from baseline at 6 months
次要结局
未报告次要终点
研究者
Xinli Zhou，MD，PHD
Xinli Zhou
Shandong Provincial Hospital