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临床试验/NCT03680248
NCT03680248已完成不适用

Monitoring of Hepatic Fat Metabolism Using Magnetic Resonance Methods

Institute for Clinical and Experimental Medicine2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2016年4月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
2
主要终点
Hepatic fat content

研究概览

简要总结

The first primary research objective of the study is to determine whether high-fat load (150 g of fat) induces increase in hepatic fat content (HFC) three and six hours after meal in insulin-sensitive subjects with normal HFC (<5% of fat) and in non-diabetic subjects with an increased HFC (>5% of fat). Furthermore, the other objective of the study is to determine whether the response of HFC to a high-fat load is affected by coadministration of glucose or fructose.

详细描述

The epidemic of non-alcoholic fatty liver disease (NAFLD) is becoming a major challenge faced by health system worldwide. The hepatic fat comes from the major sources - non-esterified fatty acids (NEFA) released from adipose tissue, dietary fat and de novo lipogenesis. Fat accumulation in the liver then occurs when triglycerides (TG) that are formed are not rapidly enough oxidized or secreted from the liver in very low density lipoproteins (VLDL). It can be hypothesized that the capacity of the liver to eliminate TG can be overcome after high load of dietary fat. High-fat load should induce an immediate accumulation of hepatic fat that could be detected using 1H magnetic resonance spectroscopy (1H-MRS). The accumulation of liver fat can be also affected by coadministration of simple carbohydrates - glucose and fructose. The administration of these carbohydrates can have a pronounced impact on the availability of particular sources of hepatic fat.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • normal response to oral glucose tolerance test
  • normal glycated hemoglobin
  • normal aspartate aminotransferase (AST)
  • normal alanine aminotransferase (ALT)

排除标准

  • BMI > 30 kg/m2
  • use of pharmacological agents affecting insulin sensitivity
  • use of pharmacological agents affecting lipid metabolism
  • inability to undergo 1H-MRS examination

结局指标

主要结局

Hepatic fat content

时间窗: Before time 0 hour, 3 hours, 6 hours

Change in hepatic fat content as determined by proton magnetic resonance spectroscopy (%) between 0 and 6 hours

次要结局

  • Insulin(before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours)
  • TG(before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours)
  • NEFA(before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours)
  • Glucose(before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours)
  • Glucagon(before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours)

研究者

发起方
Institute for Clinical and Experimental Medicine
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Jan Kovar

Head of the laboratory

Institute for Clinical and Experimental Medicine

研究点 (2)

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