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临床试验/NCT02337660
NCT02337660已完成不适用

Involvement of Steatosis-induced Glucagon Resistance in Hyperglucagonaemia

University Hospital, Gentofte, Copenhagen2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Amino acid metabolism

研究概览

简要总结

The purpose of this study is to examine whether non-alcoholic fatty liver disease (NAFLD) is associated with hepatic glucagon resistance and hyperglucagonemia.

详细描述

Hyperglucagonemia is a common condition in obesity, prediabetes and type 2 diabetes. It increases the hepatic glucose production, thus contributing to type 2-diabetic hyperglycemia. In the current study we wish to examine whether non-alcoholic fatty disease (NAFLD) results in hepatic glucagon resistance. This could result in hyperglucagonemia through a feedback mechanism acting on the level of pancreatic alpha cells. Cirrhosis and type 1 diabetes, respectively, has previously been shown to be associated with hepatic glucagon resistance but it has not been examined in relation to NAFLD in humans so far.

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
25 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Normal fasting plasma glucose and HbA1c < 6.0%
  • Between 18.5 and 25 kg/m2 or between 30 and 40 kg/m2
  • Normal haemoglobin
  • Normal coagulation factor II, VII and X, INR and thrombocytes
  • Age above 25 years
  • Informed consent

排除标准

  • Prediabetes (impaired glucose tolerance and/or impaired fasting plasma glucose)
  • First-degree relatives with diabetes
  • Nephropathy (eGFR < 60ml/min and/or albuminuria)
  • Liver disease (ALAT and/or serum ASAT >2x normal values)
  • Use of anticoagulative medicine like Clopidogrel og Warfarin
  • Pregnancy and/or breastfeeding
  • Age above 80 years
  • Any condition that the investigator feels would interfere with trial participation

研究组 & 干预措施

Healthy, lean

Experimental

15 healthy, lean subjects.

Will have a liver biopsy, and on the experimental day a pancreatic clamp will be performed.

干预措施: Liver biopsy (Procedure)

Healthy, lean

Experimental

15 healthy, lean subjects.

Will have a liver biopsy, and on the experimental day a pancreatic clamp will be performed.

干预措施: Pancreatic clamp (Other)

Obese, otherwise healthy

Experimental

15 obese, otherwise healthy subjects

Will have a liver biopsy, and on the experimental day a pancreatic clamp will be performed.

干预措施: Liver biopsy (Procedure)

Obese, otherwise healthy

Experimental

15 obese, otherwise healthy subjects

Will have a liver biopsy, and on the experimental day a pancreatic clamp will be performed.

干预措施: Pancreatic clamp (Other)

结局指标

主要结局

Amino acid metabolism

时间窗: 0-180 min

Endogenous glucose production

时间窗: 0-180 min

次要结局

  • Degree of steatosis(baseline)
  • Total RNA sequencing of liver biopsies(baseline)

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

Malte Palm Suppli

Research year assistant

University Hospital, Gentofte, Copenhagen

研究点 (2)

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