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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Washington University School of Medicine.
Recruitment status was  Recruiting
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: March 7, 2012
Last verified: March 2012
  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:

Biospecimen Retention:   Samples With DNA

Blood Samples.


Estimated Enrollment: 20
Study Start Date: July 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949403

Contacts
Contact: Deborah Delano, RN 314-747-3876 delanod@mir.wustl.edu
Contact: Kitty Krupp, RN 314-747-0183 Kruppk@mir.wustl.edu

Locations
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Deborah Delano, RN    314-747-3876    delanod@mir.wustl.edu   
Contact: Kitty Krupp, RN    314-747-0183    kruppk@mir.wustl.edu   
Principal Investigator: Robert Gropler, MD         
Washington University School of Medicine Not yet recruiting
St.Louis, Missouri, United States, 63110
Contact: Deborah Delano, RN    314-747-3876    delanod@mir.wustl.edu   
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: March 7, 2012
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 April 22, 2014