Condition: Metabolic-dysfunction Associated Steatotic Liver Disease · Sponsor: Michigan State University
This phase 2 trial is a single-site sequential, multiple assignment, randomized trial (SMART) to test and construct a high-quality adaptive intervention of essential amino acids (EAA) and/or Low Sugar Diet for children with metabolic dysfunction associated steatotic liver disease (MASLD) and increased cardiometabolic risk. The basis for the trial includes high-quality pilot data in both EAA for hepatic steatosis and a low sugar diet for hepatic steatosis. In the trial, children aged 11-17 years old will be eligible to participate if their BMI is greater than or equal to 95th% at baseline and hepatic steatosis is greater than or equal to 8% at baseline by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) because this is the most common age group diagnosed with metabolic-dysfunction associated steatotic liver disease.
This description comes directly from the study's public registry record.
Miriam B Vos, MD, MSPH · 616-267-2100 · miriam.vos@msu.edu
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| Corewell Health West | Grand Rapids, Michigan, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07459504