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NCT03674528Completed

Technical Validation of MR Biomarkers of Obesity-Associated NAFLD

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

Source: ClinicalTrials.gov · Last updated 19 Sept 2024

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Observational
Enrollment
152 (actual)
First submitted
3 Jul 2018
Start date
4 May 2018
Primary completion date
11 Jun 2024
Lead sponsor
University of Wisconsin, Madison
NCT number
NCT03674528

What you commit to

  • Study type: Observational
  • Participants enrolled: 152
  • From 4 May 2018 to the primary completion date, 11 Jun 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Regular \& excessive alcohol consumption within 2 years prior to recruitment
  • Use of steatogenic or hepatotoxic drugs

Other illness

  • Known liver malignancies

Lab values

  • Clinical or laboratory evidence of liver disease other than Nonalcoholic fatty liver disease (NAFLD)/ Nonalcoholic steatohepatitis (NASH) (e.g. HCV Ab, HBV Ab, ceruloplasmin)
  • The subject has increased bleeding risk (i.e., decreased platelets, von Willebrand disease)

Other

  • Contraindications to MRI
  • Girth or weight that exceeds scanner capacity
  • Women of childbearing potential that are pregnant or will be attempting to become pregnant during the study duration.

Who the study is looking for

  • Age of at least 18 years
  • Severely obese (BMI ≥ 35 kg/m2) patient
  • Cleared for weight-loss surgery
  • Willing and able to complete all safety and follow-up procedures
  • Willing to allow for the banking of biological samples

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of California San Diego
Coordinator of this site? Confirm its status
La JollaUnited StatesUnknown status
University of Wisconsin - Madison
Coordinator of this site? Confirm its status
MadisonUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.