Abundance and Distribution of Lipids and Proteins in Nonalcoholic Fatty Liver Disease (NAFLD)
December 9, 2025 updated by: Charles R. Flynn, Vanderbilt University
Relative Abundance and Spatial Distribution of Lipids and Proteins in Nonalcoholic Fatty Liver Disease (NAFLD)
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.
Study Overview
Status
Enrolling by invitation
Conditions
Study Type
Observational
Enrollment (Estimated)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Subjects having bariatric surgery or elective abdominal surgery at Vanderbilt University Medical Center
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Obese, bariatric surgery, liver biopsy
Obese subjects approved and scheduled for bariatric surgery at Vanderbilt University Medical Center
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Normal BMI, abdominal surgery, liver biopsy
Normal weight subjects having elective abdominal surgery at Vanderbilt University Medical Center.
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Liver transplantation donors and recipients
All livers made available for implantation or explantation will be eligible.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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2 years
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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
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Charles R Flynn, PhD, Vanderbilt University Medical Center
- Study Chair: Najji Abumrad, MD, Vanderbilt University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Study Registration Dates
First Submitted
September 22, 2009
First Submitted That Met QC Criteria
September 23, 2009
First Posted (Estimated)
September 24, 2009
Study Record Updates
Last Update Posted (Estimated)
December 18, 2025
Last Update Submitted That Met QC Criteria
December 9, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB #090657
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.