NCT01400191已完成4 期
The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1 (OCT1) in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Endogenous glucose production
研究概览
简要总结
The aim of the study is to evaluate the pharmacodynamic impact of metformin in healthy Caucasian volunteers with and without single polymorphisms M420del or R61C in OCT1, thus the study hypothesis is that metformin only affect the hepatic gluconeogenesis in healthy volunteers with functional OCT1-transporters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
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
- 是
入选标准
- •Healthy volunteers
- •Written consent
- •Genotyped in OCT1 for (M420del and R61C)
排除标准
- •Daily medication
- •Alcohol abuse
- •Pregnancy
- •Breastfeeding
研究组 & 干预措施
Homozygote wildtype OCT1
Active Comparator
干预措施: Metformin (Drug)
Heterozygote OCT1
Active Comparator
干预措施: Metformin (Drug)
Homozygote OCT1 variant
Active Comparator
干预措施: Metformin (Drug)
结局指标
主要结局
Endogenous glucose production
时间窗: 48 hours
次要结局
未报告次要终点
研究者
Mette Marie Hougaard Christensen
MD
University of Southern Denmark
研究点 (1)
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