Clinical Trial: Liver Positron Emission Tomography (PET) Study of Non Alcoholic Fatty Liver Disease

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: An Interdisciplinary Approach to the Study of Non-alcoholic Fatty Liver Disease

Brief Summary: The purpose of this study is to evaluate how the liver receives and uses fats for energy. This will help the investigators further understand the physical and chemical processes responsible for Non-Alcoholic Fatty Liver Disease (NAFLD) in overweight females with or without NAFLD who are scheduled to undergo gastric bypass surgery.

Detailed Summary:

This study involves a multidisciplinary approach that will address the metabolic mechanisms responsible for Non-alcoholic Fatty Liver Disease (NAFLD) in humans. Nonalcoholic fatty liver disease (NAFLD) has become an important public health problem in many industrialized countries because of its high prevalence, potential progression to severe liver disease, and association with cardiometabolic abnormalities, including diabetes, the metabolic syndrome, dilated cardiomyopathy, and coronary heart disease. Although obesity is an important risk factor for NAFLD many obese persons have minimal or no steatosis. The mechanism responsible for the pathogenesis of steatosis is not known, but must involve one or more of the following:

  1. Increased hepatic fatty acid (FA) delivery
  2. Decreased hepatic FA oxidation
  3. Increased de novo lipogenesis (DNL)
  4. Inadequate hepatic triglyceride secretion

We hypothesize that alterations in all of these metabolic processes are involved in the pathogenesis of NAFLD. However, a comprehensive evaluation of these factors in individual cohorts of subjects has never been performed, and the ability to measure hepatic FA oxidation in vivo in human subjects has not been available.

The following Specific Aims will be evaluated in obese women with and without NAFLD, who are scheduled for bariatric surgery:

  1. Determine hepatic FA uptake and oxidation by using novel PET techniques in combination with measurements of DNL using stable isotope tracers and by assessing liver tissue FA oxidative capacity by evaluating gene expression of FA oxidative enzyme
    Sponsor: Washington University School of Medicine

    Current Primary Outcome:

    • Hepatic Fatty Acid Uptake [ Time Frame: 3 hours ]
      Liver fatty acid uptake as determined by 1-11C-palmitate PET imaging.
    • Hepatic Fatty Acid Oxidation [ Time Frame: 3 hours ]
      Liver fatty acid oxidation as determined by 1-11C-palmitate PET imaging.
    • Hepatic DNL [ Time Frame: 3 hours ]
      DNL (de-novo lipogenesis) as determined by 13C-acetate PET imaging.


    Original Primary Outcome:

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Washington University School of Medicine

    Dates:
    Date Received: July 28, 2009
    Date Started: July 2010
    Date Completion: January 2017
    Last Updated: January 27, 2016
    Last Verified: January 2016