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临床试验/NCT01869621
NCT01869621已完成1 期

The Relation Between Heritability and the Trough Concentration of Metformin in Plasma Under Steady-state in Twins

University of Southern Denmark1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
34
试验地点
1
主要终点
Heritability

研究概览

简要总结

The trough concentration of metformin will be examined in monozygotic and dizygotic twins. Current twin study will determine the total weight of genetics on the trough concentration of metformin.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-40 years
  • Both twins has to be included
  • Dizygotic twin pairs has to be same sex
  • Informed consent given
  • Healthy condition

排除标准

  • Chronical/daily alcohol abuse
  • Hypersensitivity to metformin
  • Ingestion of drugs containing topiramate or x-ray contrast fluids
  • For women: Positive pregnancy test/breastfeeding at the beginning of the trial. No use of safe anticonceptives

研究组 & 干预措施

Metformin

Experimental

6 days treatment with metformin

干预措施: Metformin (Drug)

结局指标

主要结局

Heritability

时间窗: After 6 days of metformin treatment

The trough concentrations of metformin in twin pairs will be used to determine the effect of heritability on metformin trough concentrations. This will give insight to the weight that genetic factors have on metformin pharmacokinetics at steady-state.

次要结局

  • Single nucleotide polymorphisms (SNPs)(After 6 days treatment with metformin)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tore B. Stage

MSc Pharm

University of Southern Denmark

研究点 (1)

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