Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Charles R. Flynn, Vanderbilt University Identifier:
First received: September 22, 2009
Last updated: February 21, 2014
Last verified: February 2014

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.

Nonalcoholic Fatty Liver Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Relative Abundance and Spatial Distribution of Lipids and Proteins in Nonalcoholic Fatty Liver Disease (NAFLD)

Resource links provided by NLM:

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

liver biopsy, blood, plasma

Estimated Enrollment: 45
Study Start Date: October 2009
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years to 65 Years
Genders 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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00983463

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

No publications provided

Responsible Party: Charles R. Flynn, Assistant Professor, Vanderbilt University Identifier: NCT00983463     History of Changes
Other Study ID Numbers: IRB #090657
Study First Received: September 22, 2009
Last Updated: February 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Nonalcoholic fatty liver disease (NAFLD)
Nonalcoholic steatohepatitis (NASH)

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases processed this record on February 27, 2015