Clinical epidemiology of non-alcoholic fatty liver disease in children and adolescents. The LiverKids: Study protocol

PLoS One. 2023 Oct 13;18(10):e0286586. doi: 10.1371/journal.pone.0286586. eCollection 2023.

Abstract

Background: Non-alcoholic fatty liver disease (NAFLD) is rapidly increasing alongside overweight and obesity, not only in adults but also in children and adolescents. It is unknown what impact the development of NAFLD in childhood may have in later life. The importance of early detection and treatment lies in its potential for progression to cirrhosis, liver cancer and liver-related death, as well as its associated extrahepatic comorbidities. Vibration-Controlled Transient Elastography (VCTE) with Controlled Attenuation Parameter (CAP) is an effective, non-invasive and safe diagnostic method to estimate the degree of fibrosis and steatosis in the liver, but little is known about its applicability in the paediatric population.

Aims: 1) To assess the prevalence of significant liver fibrosis (Liver Stiffness Measurement (LSM) ≥6.5 kPa) using VCTE, and that of non-alcoholic fatty liver disease (≥225 dB/m) using CAP in children and adolescents. 2) To determine the optimal cut-off points of the CAP to achieve maximum concordance with the Magnetic Resonance Imaging (MRI) findings in the diagnosis of mild, moderate and severe NAFLD in children and adolescents.

Methods: Cross-sectional population-based study which will include 2,866 subjects aged between 9 and 16 years. Participants will undergo: anamnesis, physical examination, blood extraction, VCTE, MRI and questionnaires on socio-demographic data, personal and family medical history and lifestyle assessment.

Applicability and relevance: The study aims to establish the foundations for the use of VCTE in children and adolescents in order to achieve early diagnosis of NAFLD. Moreover, it will serve to understand in further detail the disease and to identify the risk groups of children and adolescents who may be at risk of developing it. Ultimately, this will help determine to which subgroups of the population we need to target resources for prevention and early detection of this entity, as well as possible intervention for its treatment.

Trial registration: The LiverKids study is registered on Clinicaltrials.gov (NCT05526274).

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adolescent
  • Child
  • Cross-Sectional Studies
  • Elasticity Imaging Techniques* / methods
  • Fibrosis
  • Humans
  • Liver / diagnostic imaging
  • Liver / pathology
  • Liver Cirrhosis / pathology
  • Non-alcoholic Fatty Liver Disease* / diagnostic imaging
  • Non-alcoholic Fatty Liver Disease* / epidemiology

Associated data

  • ClinicalTrials.gov/NCT05526274

Grants and funding

This study has received public funding, via an external competitive call, from the Departament de Salut (Generalitat de Catalunya) through the PERIS 2021 program, under the “Grants for research projects oriented to Primary Health Care” call for proposals. The project has been funded under the title "Clinical epidemiology of non-alcoholic fatty liver disease in children and adolescents. LiverKids Study." and under the file number "SLT/21/000047". The funding agency has not been and will not be involved in any way in the development of this study, neither in the design, collection, analysis and interpretation of data, nor in the writing of this manuscript.