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临床试验/NCT01749163
NCT01749163已完成不适用

Determining the Extra-pancreatic Effects of Incretin Hormones During Euglycemic and Hyperglycemic Pancreatic Clamps

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Glucose metabolism

研究概览

简要总结

Incretin hormones (GLP-1 and GIP) released from the intestine in response to meal ingestion augment insulin secretion from the pancreas to help maintain glycemic control. Studies in vitro and in vivo have shown that these incretin hormones also have functional effects in other tissues independent of the insulin secretory response. Both GLP-1 and GIP stimulate insulin secretion in a glucose-dependent manner, however the glucose-dependency of their extra-pancreatic effects has not been examined in vivo. By using pancreatic clamp methodology during euglycemic and hyperglycemic conditions we will test the hypothesis that extra-pancreatic effects of GLP-1 and GIP are glucose-dependent.

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
18 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • age 18-60 years
  • BMI 18-30 kg/m2
  • Normal glycemic control (fasting glucose <5.6 mM)

排除标准

  • Evidence of chronic disease
  • Active weight loss (>2 kg in previous 6 months)
  • Treatment with drugs known to affect our outcome varaibles

研究组 & 干预措施

GLP-1

Experimental

GLP-1 will be infused intravenously during the pancreatic clamp at 0.5 pmol/kg/min

干预措施: GLP-1 (Biological)

结局指标

主要结局

Glucose metabolism

时间窗: up to 4 hours

Pancreatic clamp will be performed including infusion of somatostatin and replacement of basal insulin, glucagon, and growth hormone. During pancreatic clamps, euglycemia (5 mM) will be maintained via exogenous glucose infusion for the first 2-hours, followed by hyperglycemia (+5 mM) for the final 2-hours. An infusion of the stable isotope \[U13C\]glucose will be performed to assess glucose kinetics. Expired air will be collected for the analysis of \[U13C\]glucose into 13CO2.

Lipid metabolism

时间窗: up to 4 hours

An infusion of the stable isotope \[D5\]glycerol will be performed to assess glycerol kinetics.

次要结局

  • Endothelial function(Baseline, 2 hours, and 4 hours)
  • Signaling(Baseline, 2 hours, and 4 hours)

研究者

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

Thomas Solomon

Senior Researcher

Rigshospitalet, Denmark

研究点 (1)

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