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临床试验/NCT01397279
NCT01397279已完成不适用

Assessment of Liver Glucose Metabolism in Diabetic Subjects

German Diabetes Center2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2011年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
2
主要终点
M Value in hyperinsulinemic euglycemic clamp

研究概览

简要总结

Type 2 diabetes is associated with hepatic insulin resistance. One consequence of insulin resistance of the liver is an altered hepatic glucose metabolism. This study investigates whether the whole body (M-value) and hepatic insulin sensitivity obtained by hyperinsulinemic euglycemic clamp is influenced by a preceding intravenous glucose tolerance test (Botnia Clamp) in subjects with type 2 diabetes.

详细描述

The hyperinsulinemic euglycemic clamp represents the gold standard for measuring peripheral insulin sensitivity. The insulin sensitivity is described by the M-value,which is calculated from glucose infusion rates during the last 30min of the clamp.

Glucose is metabolised in the periphery: 50% by neural tissues, 20% by splanchnic bed and liver, 15% by skeletal muscle, 5% by adipose tissue and 10% by blood cells and other tissues. Under hyperinsulinemic conditions there is a strong shift in glucose utilization: 85% skeletal muscle and 15% by neural tissues, splanchnic bed and liver, adipose tissue, blood cells and other tissues. The contribution of skeletal muscle varies with different insulin sensitivity.

We now want to investigate whether there is a difference in tissue-specific insulin sensitivity measured from a Botnia clamp (intravenous glucose tolerance test (ivGTT) and following clamp) and a single hyperinsulinemic euglycemic clamp? After a 60min ivGTT blood glucose levels in type 2 diabetic subjects are still elevated compared to baseline. High blood glucose levels can influence several parameters and may also affect insulin sensitivity. Until now, it is not proven, that the clamp preceding ivGTT does not have a significant influence on the M-value.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
35 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • newly diagnosed type 2 diabetes (during the last 12 months)or non-diabetic subjects

排除标准

  • severe chronic diseases
  • hepatitis B, C oder HIV infection
  • malignancies
  • immune suppressive therapy
  • psychiatric illnesses
  • drug or alcohol abuse
  • renal dysfunction

结局指标

主要结局

M Value in hyperinsulinemic euglycemic clamp

时间窗: 3h

measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp

次要结局

  • Insulin-suppressed endogenous glucose production (liver insulin sensitivity)(3h)

研究者

发起方
German Diabetes Center
申办方类型
Other
责任方
Sponsor

研究点 (2)

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