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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Barnes-Jewish Hospital
Information provided by (Responsible Party):
Robert Gropler, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00949403
First received: July 28, 2009
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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
Fatty Liver

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Interdisciplinary Approach to the Study of Non-alcoholic Fatty Liver Disease

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Hepatic Fatty Acid Uptake [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Liver fatty acid uptake as determined by 1-11C-palmitate PET imaging.

  • Hepatic Fatty Acid Oxidation [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Liver fatty acid oxidation as determined by 1-11C-palmitate PET imaging.

  • Hepatic DNL [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    DNL (de-novo lipogenesis) as determined by 13C-acetate PET imaging.


Biospecimen Retention:   Samples With DNA

Blood Samples.


Estimated Enrollment: 20
Study Start Date: July 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949403

Locations
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
Washington University School of Medicine
St.Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Barnes-Jewish Hospital
Investigators
Principal Investigator: Robert J Gropler, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Robert Gropler, Professor of Radiology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00949403     History of Changes
Other Study ID Numbers: 09-0621
Study First Received: July 28, 2009
Last Updated: May 2, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 19, 2014