NCT02920801已完成4 期
Study About Effect of Saxagliptin on Circulating Endothelial Progenitor Cells and Endothelial Function in Newly Diagnosed Type 2 Diabetic Patients
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- endothelial progenitor cell
研究概览
简要总结
In this study, the investigators aim to investigate whether saxagliptin modulate endothelial progenitor cells number and flow-mediated dilation in newly diagnosed, treatment-naive type 2 diabetic patients.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed type 2 diabetics (diagnosis were made according to the American Diabetes Association Guideline [19] ), treatment naive, age 30-75, hemoglobin A1c (HbA1c) ≥6.5%, fasting c-peptide >1.0ng/L
排除标准
- •pregnancy or lactation, smoker, acute disease or infection, chronic renal disease (estimated glomerular filtration rate <60 mL/min/1.73m2), live enzymes 3 times above the normal range, positive islet autoantibody, fasting c-peptide <1.0ng/L, severe hypertriglyceridemia (triglyceride >5.6mmol/L), cardiovascular events or surgery within 3 months, taking glucocorticoid, history of acute or chronic pancreatitis, pancreatic tumor, severe cardiac or pneumonic disease.
研究组 & 干预措施
saxagliptin group
Experimental
saxagliptin group consumed saxagliptin 5mg per day for 12 week
干预措施: saxagliptin (Drug)
metformin group
Active Comparator
metformin group consumed metformin 1500mg per day for 12 week
干预措施: Metformin (Drug)
结局指标
主要结局
endothelial progenitor cell
时间窗: 12weeks
flow-mediated dilation
时间窗: 12weeks
次要结局
- fasting blood glucose(12weeks)
- HbA1c(12weeks)
- liver function test(12weeks)
- renal function test(12weeks)
- 2 hour postprandial blood glucose(12weeks)
研究者
Yan Ling
associate professor
Shanghai Zhongshan Hospital
研究点 (1)
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