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临床试验/NCT05391581
NCT05391581已完成不适用

The Role of the Intestinal Hormones Glucose-dependent Insulinotropic Polypeptide (GIP) and Glucagon-like Peptide 2 (GLP-2) in Postprandial Splanchnic Blood Flow Distribution and Metabolism in Humans

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Redistribution of splanchnic blood flow (functional MRI)

研究概览

简要总结

This project will describe the mechanisms of action and the relative contributions of GIP and GLP-2 to changes in gastrointestinal blood flow induced by oral glucose, exogenous GIP and GLP-2 infusions, and endogenous GIP and GLP-2 with the use of two novel receptor antagonists GIP(3-30)NH2 and GLP-2(3-33) in healthy individuals.

详细描述

Each participant will attend eight independent randomised experimental days in the MRI-scanner with intravenous infusion (hormone/placebo), subcutaneous injection (hormon/placebo) and oral ingestion (glucose/water). On experimental day A-C, an intravenous infusion of saline, GIP(3-30)NH2, or GLP-2(3-33), respectively, starts at time point -20 minutes. On experimental day D-F, the same infusions are combined with an oral glucose tolerance test (75 gram of glucose dissolved in 250 ml water ingested orally) at time point 0 minutes. On experimental days G-H, a subcutaneous injection of either GIP or GLP-2 at time point 0 minutes is performed (positive control) during saline infusion and oral water ingestion.

MRI measurements are repeatedly performed and blood samples are drawn to be analysed for endocrine responses from the intestines, pancreas, and bones.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • No first degree relatives with diabetes
  • BMI 20-27 kg/m2

排除标准

  • Not MRI-compatible implants
  • Claustrophobia
  • Abnormal kidney or liver function
  • Planned weight loss or change in diet
  • Hypertension
  • Other conditions that could be expected to affect the primary or secondary outcomes

结局指标

主要结局

Redistribution of splanchnic blood flow (functional MRI)

时间窗: 90 minutes

Flow in mesenteric superior artery

次要结局

  • CTX (bone resorption marker)(90 minutes)
  • Heart rate(90 minutes)
  • Flow in hepatic artery(90 minutes)
  • GLP-2 levels(90 minutes)
  • GLP-2(1-33) levels(90 minutes)
  • C-peptide(90 minutes)
  • Insulin(90 minutes)
  • GIP(3-30)NH2 levels(90 minutes)
  • Liver oxygen content(90 minutes)
  • Glucagon(90 minutes)
  • Glucose(90 minutes)
  • P1NP (bone formation marker)(90 minutes)
  • GIP levels(90 minutes)
  • Flow in coeliac trunk(90 minutes)
  • Flow in portal vein(90 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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