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

Fan Yang,1,2,* Mengyuan Hu,3,* Haoyang Zhang,1 Xiaowei Zheng,2 Limei Chen,4 Lihong Zhu,1 Le Zhang1 1Department of Pediatric Laboratory, Affiliated Children’s Hospital of Jiangnan University (Wuxi Children’s Hospital), Wuxi, People’s Republic of China; 2Wuxi School of Medicine, Jiangnan University, Wuxi, People’s Republic of China; 3Department of Paediatrics, Jinhua Maternal and Child Health Hospital, Jinhua, 214023, People’s Republic of China; 4Research Base for Environment and Health in Wuxi, Chinese Center for Disease Control and Prevention, Wuxi, 214023, People’s Republic of China*These authors contributed equally to this workCorrespondence: Le Zhang; Lihong Zhu, Email [email protected]; [email protected]: 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).Keywords: MASLD, student, incidence, VCTE, cohort study