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Abundance and Distribution of Lipids and Proteins in Nonalcoholic Fatty Liver Disease (NAFLD)

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ClinicalTrials.gov Identifier: NCT00983463
Recruitment Status : Enrolling by invitation
First Posted : September 24, 2009
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Charles R. Flynn, Vanderbilt University

Brief Summary:
Nonalcoholic fatty liver disease (NAFLD) is the most common type of liver disease in the United States. The incidence of NAFLD is very similar to that of obesity, type 2 diabetes, and the metabolic syndrome. The investigators hypothesize that there may be a relationship between over-nutrition, decreased physical activity and the development of fatty liver. The purpose of this study is to identify the types of fats and proteins, and the quantity of each, that are associated with increased severity of NAFLD.

Condition or disease
Nonalcoholic Fatty Liver Disease

Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Relative Abundance and Spatial Distribution of Lipids and Proteins in Nonalcoholic Fatty Liver Disease (NAFLD)
Study Start Date : October 2009
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018


Group/Cohort
Obese, bariatric surgery, liver biopsy
Obese subjects approved and scheduled for bariatric surgery at Vanderbilt University Medical Center
Normal BMI, abdominal surgery, liver biopsy
Normal weight subjects having elective abdominal surgery at Vanderbilt University Medical Center.
Liver transplantation donors and recipients
All livers made available for implantation or explantation will be eligible.



Primary Outcome Measures :
  1. To identify and relatively quantify, using high performance liquid chromatography electrospray ionization mass spectrometry, select lipids and proteins present in human liver biopsies. [ Time Frame: 2 years ]
  2. To spatially profile, using matrix assisted laser desorption ionization time of flight mass spectrometry, select lipids and proteins present in human liver biopsies. [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
liver biopsy, blood, plasma


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects having bariatric surgery or elective abdominal surgery at Vanderbilt University Medical Center
Criteria

Inclusion Criteria:

  • 18-65 year of age
  • Undergoing elective abdominal or bariatric surgery
  • May have normal or elevated ALT/AST levels

Exclusion Criteria:

  • Presence of viral hepatitis
  • Significant alcohol use
  • Intercurrent infections
  • Use of any thiazolidinediones

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 ClinicalTrials.gov identifier (NCT number): NCT00983463


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Charles R Flynn, PhD Vanderbilt University Medical Center
Study Chair: Najji Abumrad, MD Vanderbilt University Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Charles R. Flynn, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00983463     History of Changes
Other Study ID Numbers: IRB #090657
First Posted: September 24, 2009    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Keywords provided by Charles R. Flynn, Vanderbilt University:
Nonalcoholic fatty liver disease (NAFLD)
Nonalcoholic steatohepatitis (NASH)
Obesity
Lipidomics
Proteomics

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