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

Sponsor
Vanderbilt University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT00983463
Collaborator
(none)
45
Enrollment
1
Location
181
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Oct 1, 2009
    Anticipated Primary Completion Date :
    Nov 1, 2024
    Anticipated Study Completion Date :
    Nov 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    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. [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. [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Charles R. Flynn, Assistant Professor, Vanderbilt University
    ClinicalTrials.gov Identifier:
    NCT00983463
    Other Study ID Numbers:
    • IRB #090657
    First Posted:
    Sep 24, 2009
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Jul 1, 2022
    Keywords provided by Charles R. Flynn, Assistant Professor, 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

    Study Results

    No Results Posted as of Jul 7, 2022