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临床试验/NCT02235584
NCT02235584已完成不适用

Loss of Insulinotropic Properties of Glucagon-like Peptide-1 (GLP-1) and Glucose-dependent Insulinotropic Peptide (GIP) After Glucocorticoid Induced Insulin Resistance

Hvidovre University Hospital1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
The potentiating effects of GLP-1 on second phase insulin response when clamped at at bloodsugar of 7 mmol/l

研究概览

简要总结

In this study we examine whether inducing insulin resistance by dexamethasone in healthy volunteers will lead to a decreased insulinotropic effect of the hormones GLP-1 and GIP.

详细描述

In this study we are going to examine the insulinotropic properties of GLP-1 and GIP before and after the development of insulin resistance and/or glucose intolerance.The insulinotropic properties of GLP-1 and GIP are greatly reduced in type 2 diabetes.

Since the development of type 2 diabetes is preceded by insulin resistance and glucose intolerance we wanted to examine the insulinotropic properties of GLP-1 and GIP in the early stages of type 2 diabetes.

To do this, we want to induce insulin resistance and/or glucose intolerance. This is achieved by 5 days of treatment with dexamethasone.

Subjects are studied on 4 different days in randomized order, with an oral glucose tolerance test (OGTT) and glucose clamps + infusions of GLP-1, GIP and NaCl before and immediately after 5 days treatment with dexamethasone, 2mg bid. On day 1, 2 and 3 after the 5 days of dexamethasone, 2mg dexamethasone was given in the afternoon after the tests to ensure unchanged insulin resistance

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
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Caucasians above 20 and below 45 years of age
  • Normal glucose tolerance as assessed by the WHO criteria
  • First degree relative and at least 1 second degree relative with type 2 diabetes
  • Normal haemoglobin
  • Informed consent

排除标准

  • Liver disease (ALAT/ASAT > 2 times normal value)
  • Kidney disease (S-creatinin > 130uM and/or albuminuria)
  • Heart disease (NYHA II, III or IV)
  • Treatment with medicine that cannot be paused
  • Pregnancy of breast feeding

研究组 & 干预措施

Dexamethasone

Experimental

This is a before-after study. All subjects are administered dexamethasone 2mg BID for 5 days.

干预措施: Dexamethasone (Drug)

结局指标

主要结局

The potentiating effects of GLP-1 on second phase insulin response when clamped at at bloodsugar of 7 mmol/l

时间窗: 1-3 days after dexamethasone treatment

After dexamethasone treatment subjects are tested with infusion of GLP-1 during a clamped blood-sugar of 7mmol/l. Their increase in the second phase insulin response is the primary endpoint.

次要结局

  • First phase insulin response to GLP-1 infusion at 7mmol/l(1-3 days after dexamethasone)
  • Second phase insulin response to GIP infusion at 7mmol/l(1-3 days after dexamethasone treatment)
  • First phase insulin response to GIP infusion at 7mmol/l(1-3 days after dexamethasone)

研究者

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

Carsten Dirksen

MD

Hvidovre University Hospital

研究点 (1)

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