NCT02583438Unknown4 期
Beijing Chao-yang Hospital, Capital Medical University
Beijing Chao Yang Hospital0 个研究点目标入组 100 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 主要终点
- gut microbiota
研究概览
简要总结
The intestinal microflora imbalance has been associated with obesity and type 2 diabetes. The researchers' study aimed to investigate the effect of saxagliptin on gut microbiota in patients with newly diagnosed type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Females or males, and aged 20 to 65 years.
- •Newly diagnosed type 2 diabetes
- •HbA1C ≥7% and HbA1C <9%
排除标准
- •Hepatic insufficiency (ALT or AST> 1.5*ULN)
- •Renal insufficiency [Creatinine clearance rate (Ccr)]<60ml/min estimated from MDRD equation)
- •Coronary artery disease
- •Thyroid disease
- •Infectious disease
- •Systemic inflammatory disease
- •Subjects who were taking agents known to influence gut microbiota
- •Pregnant or lactating woman
- •Other conditions at investigator's discretion
研究组 & 干预措施
Lifestyle intervention
Experimental
干预措施: Saxagliptin (Bristol-Myers Squibb Company) (Drug)
结局指标
主要结局
gut microbiota
时间窗: Change from Baseline Bacteroidetes abundances and composition of gut microbiota at 6 months
次要结局
- The improvement of intestinal microflora imbalance(Bacteroidetes abundances and composition of gut microbiota (baseline, 4 weeks, 8 weeks and 12 weeks))
- The change of inflammatory markers(The change of inflammatory markers (baseline, 12 weeks))
研究者
Guang Wang
Department of Endocrinology
Beijing Chao Yang Hospital
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