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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00949403
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : February 7, 2018
Barnes-Jewish Hospital
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease
Fatty Liver

Detailed Description:

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 enzymes and mitochondrial content.
  2. Determine hepatic fatty acid delivery by using stable isotope tracers to assess the rate of free FA (FFA) release into plasma and cellular biology methods to determine the expression and protein content of the major tissue FA transporter (CD36).
  3. Determine hepatic very-low-density lipoprotein TG (VLDL-TG) secretion rate by using stable isotope tracers.
  4. Determine liver histology and factors involved in inflammation and fibrosis by using routine staining and immunohistochemistry.

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Interdisciplinary Approach to the Study of Non-alcoholic Fatty Liver Disease
Study Start Date : July 2010
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 19, 2018

Obese Females (pre-bariatric surgery)
Twenty obese females (18-45 years of age, BMI > or equal to 45) who are scheduled to undergo bariatric surgery at Barnes-Jewish Hospital will be screened for enrollment over 2 years.

Primary Outcome Measures :
  1. Hepatic Fatty Acid Oxidation [ Time Frame: 3 hours ]
    Liver fatty acid oxidation as determined by 1-11C-palmitate PET imaging.

Biospecimen Retention:   Samples With DNA
Blood Samples.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Obese females between the ages of 18 and 45, with a BMI of greater then or equal to 45, who are scheduled to undergo bariatric surgery at Barnes-Jewish Hospital.

Inclusion Criteria:

  • Obese females with a BMI of greater then or equal to 45.
  • Age range between 18-45 years.
  • Patients undergoing bariatric surgery at Barnes-Jewish Hospital-St.Louis,MO.

Exclusion Criteria:

  • Any prior history or evidence of liver disease other than Non-Alcoholic Fatty liver Disease, severe hypertriglyceridemia and diabetes mellitis.
  • Consumed greater then or equal to 20 grams of alcohol per day.
  • Taking medications that are known to cause hepatic steatosis & liver damage.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00949403

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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Washington University
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Barnes-Jewish Hospital
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Principal Investigator: Robert J Gropler, MD Washington University School of Medicine

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Responsible Party: Washington University School of Medicine Identifier: NCT00949403     History of Changes
Other Study ID Numbers: 09-0621
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available to other researchers

Keywords provided by Washington University School of Medicine:
Non-Alcoholic Fatty Liver disease

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases