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临床试验/NCT01176708
NCT01176708Unknown不适用

The Significance of Intact Liver Innervation for the Glucose and GLP-1 Induced Insulin Secretion

University Hospital, Gentofte, Copenhagen1 个研究点 分布在 1 个国家目标入组 30 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
发起方
入组人数
30
试验地点
1
主要终点
insulin secretion

研究概览

简要总结

The aim of the study is to investigate the significance of intact nerve supply to the liver for the glucagon-like peptide-1 (GLP-1) induced insulin secretion.

The hypothesis is that the effects of GLP-1 is transmitted through the GLP-1 receptor and that these effects involve sensory afferent neurons, probably primarily parasympathetic.

详细描述

GLP-1 is a potent enterogastron and incretin hormone. It is rapidly inactivated by dipeptidyl peptidase IV so only 10-15% enters the systemic circulation. This has led to the hypothesis that GLP-1 interact locally with afferent sensory nerve fibers.

The aim of this study is to investigate the significance of intact liver innervation for the GLP-1 induced insulin secretion in liver transplanted patients; kidney transplanted control patients matched for immunosuppressive treatment, age, gender and body weight; and ten control persons matched for age, gender and body weight.

The insulin secretion will be evaluated from blood samples that will be analyzed for insulin and c-peptide.

研究设计

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

入排标准

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

入选标准

  • normal fasting plasma glucose
  • normal hemoglobin
  • informed consent

排除标准

  • type 1 diabetes mellitus or type 2 diabetes mellitus
  • body mass index > 30
  • inflammatory bowel disease
  • intestinal surgery
  • serum creatinine > 250 µM and/or albuminuria
  • ALAT > 2 x normal value
  • Severe cardiac insufficiency
  • in treatment with medicine which cannot be paused for 12 hours

研究组 & 干预措施

Liver transplanted

Experimental

10 Liver transplanted patients

干预措施: dipeptidyl peptidase 4 (DPP4) inhibitor (Drug)

Liver transplanted

Experimental

10 Liver transplanted patients

干预措施: oral glucose (Other)

Liver transplanted

Experimental

10 Liver transplanted patients

干预措施: intravenous glucose (Other)

Kidney transplanted

Experimental

10 kidney transplanted individuals

干预措施: dipeptidyl peptidase 4 (DPP4) inhibitor (Drug)

Kidney transplanted

Experimental

10 kidney transplanted individuals

干预措施: oral glucose (Other)

Kidney transplanted

Experimental

10 kidney transplanted individuals

干预措施: intravenous glucose (Other)

Healthy controls

Experimental

10 healthy controls

干预措施: dipeptidyl peptidase 4 (DPP4) inhibitor (Drug)

Healthy controls

Experimental

10 healthy controls

干预措施: oral glucose (Other)

Healthy controls

Experimental

10 healthy controls

干预措施: intravenous glucose (Other)

结局指标

主要结局

insulin secretion

时间窗: four hours

The insulin secretion during a four-hour oral glucose tolerance test (OGTT) and an intravenous isoglycaemic clamp is evaluated

次要结局

  • plasma glucagon(12 time points within four hours)
  • plasma glucose(20 time points within four hours)
  • plasma GLP-1(12 time points within four hours)
  • plasma GIP(12 time points within four hours)
  • plasma GLP-2(12 time points within four hours)
  • plasma PYY(12 time points within four hours)

研究者

发起方
University Hospital, Gentofte, Copenhagen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonatan I Bagger

MD

University Hospital, Gentofte, Copenhagen

研究点 (1)

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