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

NCT ID: NCT00983463

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Nonalcoholic Fatty Liver Disease

Keywords

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Nonalcoholic fatty liver disease (NAFLD) Nonalcoholic steatohepatitis (NASH) Obesity Lipidomics Proteomics

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Obese, bariatric surgery, liver biopsy

Obese subjects approved and scheduled for bariatric surgery at Vanderbilt University Medical Center

No interventions assigned to this group

Normal BMI, abdominal surgery, liver biopsy

Normal weight subjects having elective abdominal surgery at Vanderbilt University Medical Center.

No interventions assigned to this group

Liver transplantation donors and recipients

All livers made available for implantation or explantation will be eligible.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Charles R. Flynn

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charles R Flynn, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Najji Abumrad, MD

Role: STUDY_CHAIR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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Garcia AE, Kasim N, Tamboli RA, Gonzalez RS, Antoun J, Eckert EA, Marks-Shulman PA, Dunn J, Wattacheril J, Wallen T, Abumrad NN, Flynn CR. Lipoprotein Profiles in Class III Obese Caucasian and African American Women with Nonalcoholic Fatty Liver Disease. PLoS One. 2015 Nov 23;10(11):e0142676. doi: 10.1371/journal.pone.0142676. eCollection 2015.

Reference Type DERIVED
PMID: 26599819 (View on PubMed)

Other Identifiers

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IRB #090657

Identifier Type: -

Identifier Source: org_study_id