NCT04426422已完成4 期
Effect of Metformin on Gut Microbiota Changes and Glycemic Control of Newly Diagnosed Type 2 Diabetes
Shenzhen People's Hospital1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2017年3月1日最近更新:
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
- 52
- 试验地点
- 1
- 主要终点
- gut micribiota
研究概览
简要总结
This study was aimed to investigate the effect of metformin on the gut microbiota and glycemic control in newly diagnosed type 2 diabetes patients.
详细描述
This study was aimed to investigate the effect of metformin on the gut microbiota and glycemic control in newly diagnosed type 2 diabetes patients. All the recurited patients were treated with metformin 1500-2000mg daily for 3 months. Stool specimens and blood samples were collected at the beginning and 3 months later.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosis type 2 diabetes ,HbA1c >7 %
排除标准
- •history of cardiovascular disease, hypertension, severe renal dysfunction defined as glomerular filtration rate < 45 mL/min/1.73 m2; severe illness or diabetic ketoacidosis within 30 days, inability to tolerate ≥500 mg metformin twice per day and pregnancy.
研究组 & 干预措施
metformin group
Experimental
all the patients were treated with metformin 1500-2000mg daily for 3 months.
干预措施: Metformin Hydrochloride (Drug)
结局指标
主要结局
gut micribiota
时间窗: 3 months
the changes of gut micribiota
次要结局
- glycemic control(3 months)
研究者
研究点 (1)
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