Protocol for a Longitudinal Cohort Study to Understand Characteristics and Risk Factors Underlying Vibration-Controlled Transient Elastography-Diagnosed Metabolic Dysfunction-Associated Fatty Liver Disease Children.

BACKGROUND

Metabolic-associated steatotic liver disease (MASLD) is a novel term proposed in 2023 to replace non-alcoholic fatty liver disease (NAFLD) with the aim of better reflecting its pathogenesis and clinical manifestations. Vibration-controlled transient elastography (VCTE) is an evidence-based, non-invasive imaging device used to evaluate liver fat deposition and fibrosis. It can effectively detect liver fat infiltration greater than 5%, which is much higher than the previous ultrasound detection rate (it is difficult to detect liver fat deposition below 30%). Nevertheless, the prevalence and characteristics of MASLD children diagnosed based on these updated criteria are currently not well established.

METHODS

Currently, a prospective multi-center population-based cohort study is being conducted in Wuxi, China, spanning from 2023 to 2035, involving 5600 children from four primary schools. Throughout the study's baseline and follow-up periods, yearly physical examinations, laboratory tests, VCTE assessments, and bioelectrical impedance analysis are being conducted to measure MASLD-related biomarkers. Additionally, a questionnaire is being administered to inquire about dietary habits. MASLD is being diagnosed based on clinical and laboratory criteria, and the corresponding prevalence is being assessed.

RESULTS

Recruitment began in March 13, 2023. To date, 1475 participants have completed the physical examination and questionnaire survey.

DISCUSSION: Our study investigated the prevalence of MASLD and its influencing factors in Chinese school-age children and adolescents. By collecting and analyzing data from physical examinations and survey questionnaires, it may propose new avenues for guiding the treatment and early-stage prevention of MASLD in children.

TRIAL REGISTRATION: Chinese Clinical Trials Registry (NO. ChiCTR2400080508).