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临床试验/NCT02363309
NCT02363309已完成不适用

Palmitate Breath Test to Assess Fatty Acid Oxidation in Non Alcoholic Fatty Liver Disease

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2015年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
1
主要终点
Measure rates of fatty acid oxidation in patients with non alcoholic fatty liver disease

研究概览

简要总结

Background:

  • Non-alcoholic fatty liver disease (NAFLD) is a common cause of abnormal liver tests. It is closely linked to health problems like obesity and diabetes. Researchers want to use a breath test to measure the metabolism of fatty acids and learn more about the causes of disease. They will compare the results between people who do and do not have NAFLD. They will also repeat the test in people with NAFLD after treatment to see improvement.

Objectives:

  • To measure the metabolism of fatty acids and compare them between people who do and do not have NAFLD, and people with NAFLD before and after treatment.

Eligibility:

  • People age 21 and older with NAFLD
  • Healthy volunteers
  • non-NAFLD metabolic syndrome

Design:

  • Participants will be screened with medical history, physical exam, and fasting blood tests.
  • Participants will fast overnight.
  • Participants will sit in a comfortable chair. They will relax for 15 minutes. Then a narrow plastic tube will be put under their nostrils. It will be connected to a breath test device.
  • Participants will drink palmitate or acetate in a heated liquid meal (Ensure). Palmitate is a fatty acid and acetate is a small molecule that is a building block for fatty acids. Both palmitate and acetate are natural compounds that are in our body and our food.
  • Participants will sit for 6 hours. They can read, watch television, work on a computer, or other relaxed activity. The air they breathe out from their nose will be collected and analyzed. They may take a bathroom break after 3 hours. They may drink water after 3 hours.
  • Participants will get a meal after the test.
  • Participants will have another visit at least 1 week later. They will repeat the test with the other compound (acetate of palmitate).
  • Participants may be asked to repeat a test to study the result of a change like weight loss or medicine. Thus, participation can last from 1 week to several years.

详细描述

NAFLD is the most common cause for liver enzyme abnormalities in the western world. It is estimated to affect approximately 30% of the US population and is closely associated with the metabolic syndrome and insulin resistance. Dysregulation of fatty acid metabolism and abnormal function of the adipose tissue is thought to be a major feature of insulin resistance and NAFLD. Whether fatty acid oxidation is also dysregulated in patients with NAFLD is unclear. In this study we aim to measure total-body fatty acid oxidation of an oral fat load using the BreathID breath test device and a meal containing 13C-labeled palmitate. Results will be compared between patients with NAFLD, healthy controls and patients with metabolic syndrome but not NAFLD, as well as within NAFLD patients before and after therapeutic interventions.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Measure rates of fatty acid oxidation in patients with non alcoholic fatty liver disease

时间窗: End of study

Differences in rates of fatty acid oxidation in patients with non alcoholic fatty liver disease.

次要结局

未报告次要终点

研究者

研究点 (1)

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