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临床试验/NCT02629705
NCT02629705已完成不适用

Investigation of the Effect of Carrageenan as Food Additive on Insulin Resistance in Humans

University Hospital Tuebingen2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Insulin sensitivity assessed by hyperinsulinemic clamp: M-value

研究概览

简要总结

The purpose of this study is to determine whether the ingestion of the common food additive carrageenan contributes to insulin resistance and thus to the pathogenesis of type 2 diabetes in humans.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • body mass index (BMI) 18.5 - 29.9 kg/m²

排除标准

  • any chronic illness
  • any ongoing medication
  • known infections
  • known liver disease
  • known renal insufficiency
  • alcohol consumption over 30 g/d
  • shift work

结局指标

主要结局

Insulin sensitivity assessed by hyperinsulinemic clamp: M-value

时间窗: 2 weeks

Insulin sensitivity assessed by oral glucose tolerance test (OGTT): Matsuda index

时间窗: 2 weeks

次要结局

  • Endogenous glucose production measured by tracer-method(2 weeks)
  • Cerebral insulin sensitivity measured by MRI(2 weeks)
  • Intrahepatic triglyceride content(2 weeks)
  • Glycemia during OGTT(2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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