Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

The overall goal of this collaborative research program is to develop, validate and translate advanced quantitative magnetic resonance (MR) biomarkers of obesity-associated non-alcoholic fatty liver disease (NAFLD). This protocol represents the research plan for two distinct phases. The first phase is an optimization phase. The second phase is designed to complete a rigorous test of conventional and advanced MRE techniques. Complementary anthropometric, laboratory, and MR measures will also be collected to characterize the cohort and identify factors that affect MRE performance

Official Title

Technical Validation of Magnetic Resonance Biomarkers of Obesity-Associated Non-Alcoholic Fatty Liver Disease

Details

The long-term objective of this research is to improve the health of the millions of Americans with or at risk for NAFLD, the most common chronic liver disease and most rapidly growing indication for liver transplantation in the United States. To achieve this objective, an advanced MR-based imaging method will be used to measure liver "stiffness" which is an early sign of disease. This technique has been previously developed and validated and ready to be used for further research. This current protocol will extend previous work by optimizing and validating advanced 2 dimensional and 3 dimensional-magnetic resonance elastography (MRE) methods as non-invasive biomarkers of hepatic inflammation and fibrosis in obese patients at risk for non-alcoholic steatohepatitis (NASH), the histologically more aggressive subset of NAFLD.

Keywords

Non-Alcoholic Fatty Liver Disease Non-alcoholic Steatohepatitis MRI MRE Liver Disease Liver Fibrosis Liver Diseases Fatty Liver Magnetic Resonance Elastography (MRE) Liver biopsy

Eligibility

You can join if…

Open to people ages 18 years and up

  • 18 years of age or older
  • BMI greater/equal to 35 kilograms per meter squared
  • Phase 2 subjects must be eligible for weight loss surgery and willing to undergo a research biopsy procedure

You CAN'T join if...

  • Unable to undergo and MRI scan
  • Women that are pregnant or breastfeeding
  • Phase 2 subjects must not have known liver disease, engage in excessive alcohol consumption, or take medication that is hepatotoxic

Locations

  • University of California, San Diego
    La Jolla California 92093 United States
  • University of Wisconsin, Madison
    Madison Wisconsin 53704 United States

Details

Status
currently not accepting new patients, but might later
Start Date
Completion Date
(estimated)
Sponsor
University of Wisconsin, Madison
ID
NCT03674528
Study Type
Observational
Last Updated