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临床试验/NCT00523562
NCT00523562已完成不适用

Study of the Role of Insulin Resistance in the Pathogenesis of the Metabolic Syndrome and of Non-alcoholic Steatohepatitis

University of Lausanne2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2006年7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
41
试验地点
2
主要终点
plasma triglycerides

研究概览

简要总结

The purpose of this study is to assess how the macronutrient composition of the diet effects

  • lipid and glucose metabolism
  • intrahepatic lipids
  • insulin sensitivity

in healthy lean subjects and in subjects with a high metabolic risk (ie overweight and offsprings of patients with type 2 diabetes mellitus).

详细描述

The study is aimed at assessing the effects of changes in total energy, sugars, lipids, and protein intake on intrahepatic lipids, plasma lipids, and hepatic and whole body insulin resistance in

  • lean men and women with no family history of diabetes
  • overweight men and women
  • lean men with a family history of type 2 diabetes

Subjects are studied after a 6-day period of

  • isocaloric diet with 100% calorie requirement, of which 55% carbohydrate, 15% protein, and 30% fat)
  • the same isocaloric diet supplemented with 3g/kg body weight/day fructose
  • hypercaloric high fat diet with 130% energy requirement, of which 55% carbohydrate, 15% protein, 60% fat
  • hypercaloric high fat+protein diet with 145% energy requirement, of which 55% carbohydrate, 30% protein, 60% fat

Measurements performed after 6 days on each diet include

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 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females
  • Age 18-40
  • Informed consent obtained
  • Subgroup with overweight (body mass index [BMI] > 25)
  • Subgroup with family history of type 2 diabetes mellitus

排除标准

  • Alcohol intake > 30g/day
  • Drug abuse
  • Diabetes mellitus
  • Any concurrent medication
  • Having a pacemaker
  • History of orthopedic surgery
  • History of metal foreign bodies

研究组 & 干预措施

normal weight male high fructose diet

Experimental

Effects of diet intervention " high fructose" in normal weight subjects

干预措施: diet intervention (Other)

offsprings of T2DM high fructose diet

Experimental

Effect of diet intervention "high fructose" in healthy non-obese offsprings of patients with type 2 diabetes

干预措施: diet intervention (Other)

normal weight subjects high fat diet

Experimental

effects of diet intervention "high fat" in healthy male subjects

干预措施: diet intervention (Other)

Normal weight high fat+protein diet

Experimental

effect of diet intervention "high fat + protein" subjects in healthy male subjects

干预措施: diet intervention (Other)

结局指标

主要结局

plasma triglycerides

时间窗: 6 days

intra-hepatic lipids

时间窗: 6 days

insulin mediated glucose disposal

时间窗: 6 days

次要结局

  • lipid oxidation(6 days)
  • plasma beta-hydroxybutyrate(6 days)
  • gene expression in skeletal muscle and adipose tissue(6 days)

研究者

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

Luc Tappy, MD

Professor Luc Tappy

University of Lausanne

研究点 (2)

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