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

NCT00983463 | Enrolling By Invitation

• 1 other identifier: IRB #090657
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Fatty Liver Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects having bariatric surgery or elective abdominal surgery at Vanderbilt University Medical Center

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 26599819 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

liver biopsy, blood, plasma

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles R Flynn, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Najji Abumrad, MD

  Vanderbilt University Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 24, 2009
• Study Start: October 1, 2009
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)