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临床试验/NCT01371396
NCT01371396已完成不适用

Effect of Dietary Macronutrient Composition on Liver Substrate Metabolism

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2007年9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
入组人数
24
试验地点
2
主要终点
de novo lipogenesis

研究概览

简要总结

The purpose of this study is to understand why Hispanics who are overweight have a higher incidence of fatty liver disease.

详细描述

Obesity is a major factor driving the increased prevalence of hepatic steatosis in the US. However, little is known regarding the relationship between dietary intake and hepatic fat deposition or about the factors that promote loss of hepatic steatosis. Here, the investigators will determine how differences in dietary composition affect the development and regression of fatty liver. The investigators hypothesize that Hispanic subjects with metabolic syndrome will have higher liver fat synthesis rates compared to African American subjects.

Using detailed in vivo, serial measurements of fuel metabolism (GC/MS and NMR) fatty acid metabolism will be measured in the liver and periphery. This will be the first study in which these two methodologies are used together to assess both glucose and fatty acid metabolism in the same subjects. Subjects will be tested before and after a dietary weight-loss intervention producing 6% body weight loss over 5 months.

The specific aims are as follows:

AIM 1: Determine the contribution of peripheral and dietary fat to liver-TG in Hispanics and African Americans with metabolic syndrome.

Hypothesis: De novo lipogenesis will contribute to liver-TG in greater quantities compared to African Americans.

研究设计

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

入排标准

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

入选标准

  • Elevated serum ALT or metabolic syndrome
  • African American or Hispanic
  • Nondiabetic
  • Men or women
  • Smokers and nonsmokers
  • Pre- and post-menopausal (+/- HRT)
  • Stable body weight
  • Age 20-65 years
  • BMI between 25-45 kg/m2

排除标准

  • Diabetes or Pregnancy
  • Ethanol intake: males > 140 g/week, females > 70 g/week
  • Chronic hepatitis B or chronic hepatitis C
  • Hemochromatosis or Wilson's Disease
  • Autoimmune hepatitis or primary biliary cirrhosis

研究组 & 干预措施

African American subjects

Other

Subjects will self-identify as African American in origin.

干预措施: Low-fat diet (Other)

Hispanic subjects

Other

Subjects will identify as Hispanic ethnicity.

干预措施: Low-fat diet (Other)

Hispanic subjects

Other

Subjects will identify as Hispanic ethnicity.

干预措施: Low-carbohydrate diet (Other)

African American subjects

Other

Subjects will self-identify as African American in origin.

干预措施: Low-carbohydrate diet (Other)

结局指标

主要结局

de novo lipogenesis

时间窗: Change from Baseline in fatty acid synthesis at 5 months

In vivo measurement is made of liver fatty acid synthesis using stable isotope administration and analysis of plasma samples by GS/MS

次要结局

  • Adipose fatty acid flux(Change from Baseline in adipose fat flux at 5 months)
  • Dietary fatty acid clearance to liver(Change from Baseline in dietary fat clearance at 5 months)

研究者

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

Elizabeth Parks

Associate Professor

University of Texas Southwestern Medical Center

研究点 (2)

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