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Sponsor: University of Wisconsin, Madison
Conditions: Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
Interventions: Magnetic Resonance Elastography (MRE), Liver biopsy
Countries: United States
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
Sex: ALL
Age: 18 Years to —
Healthy volunteers: Yes
Study type: OBSERVATIONAL
Inclusion Criteria (Phase 1 and 2 participants) * Age of at least 18 years * Severely obese (BMI ≥ 35 kg/m2) patient Inclusion Criteria (Phase 2 participants only) * 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 Exclusion Criteria (Phase 1 and 2 participants) * 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. Exclusion Criteria (Phase 2 participants only) * Known liver malignancies * Regular \& excessive alcohol consumption within 2 years prior to recruitment * Use of steatogenic or hepatotoxic drugs * 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)
- La Jolla, California, United States
- Madison, Wisconsin, United States