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NCT00983463 Clinical Trial

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

Nonalcoholic Fatty Liver Disease Clinical Trial

Official title:
Relative Abundance and Spatial Distribution of Lipids and Proteins in Nonalcoholic Fatty Liver Disease (NAFLD)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT00983463
Other study ID # IRB #090657
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 2009
Est. completion date November 2024

Study information
Verified date August 2023
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 45
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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