Clinical Epidemiology of NAFLD in Children and Adolescents (LiverKids)

Clinical Epidemiology of Non-alcoholic Fatty Liver Disease in Children and Adolescents. The LiverKids Study.

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. Objectives: 1) To assess the prevalence of significant liver fibrosis (LSM≥6,5kPa) using VCTE, and that of non-alcoholic fatty liver disease (≥225dB/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 ≥9 to ≤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.

Study Overview

• Status: Not yet recruiting
• Conditions: Childhood Obesity; Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Diagnostic test: Vibration-Controlled Transient Elastography (VCTE) with Controlled Attenuation Parameter (CAP)

• Study Type: Observational
• Enrollment (Anticipated): 2866

Contacts and Locations

• Study Contact: Name: Carmen Expósito Martínez, PhD; Phone Number: 93 741 53 38; Email: cexposito.mn.ics@gencat.cat
• Study Contact Backup: Name: Carla Chacón Valera, MS; Phone Number: 93 741 53 38; Email: cchaconv.mn.ics@gencat.cat

Study Locations

• Spain
  • Barcelona
    • Mataró, Barcelona, Spain, 08303
      • IDIAP Jordi Gol i Gurina
      • Contact: Carmen Expósito Martínez, PhD; Phone Number: 93 741 53 38; Email: cexposito.mn.ics@gencat.cat
      • Contact: Carla Chacón Valera, MS; Phone Number: 93 741 53 38; Email: cchaconv.mn.ics@gencat.cat
      • Sub-Investigator: Pere Torán Monserrat, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 16 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study will be carried out among children and adolescents aged between 9 and 16 years who are enrolled in the Spanish compulsory education system in the territory of Mataró. Since schooling at state level is compulsory in this age group, more than 90% of this population will be accessible from the schools themselves.

Description

Inclusion Criteria:

• Subjects aged between 9 and 16 years.
• Subjects whose parents/legal guardians have signed the informed consent.
• For subjects over 12 years: it will also be necessary to have their own signed informed consent.

Exclusion Criteria:

• Subjects with previously diagnosed liver disease.
• Subjects receiving hepatotoxic drug treatment.
• Subjects with diagnosed eating disorders.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
General population aged ≥9 to ≤16 years.	Diagnostic test: Vibration-Controlled Transient Elastography (VCTE) with Controlled Attenuation Parameter (CAP); VCTE with associated CAP is an effective, non-invasive and safe diagnostic method to estimate the degree of fibrosis and steatosis in the liver.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects with LSM ≥6.5 kPa by VCTE in the general population aged ≥9 to ≤16 years	2022-2024
Percentage of subjects with CAP ≥225 dB/m by VCTE in the general population aged ≥9 to ≤16 years.	2022-2024
Comparison of liver steatosis diagnosis accuracy between CAP by VCTE and MRI in the general population aged ≥9 to ≤16 years.	2022-2024
Determination of optimal cut-off points of the CAP for the diagnosis of mild, moderate and severe liver steatosis in children and adolescents.	2022-2024

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparison of liver steatosis diagnosis accuracy between CAP by VCTE and Fatty Liver Index (FLI) in the general population aged ≥9 to ≤16 years	2022-2024
Comparison of liver fibrosis diagnosis accuracy between LSM by VCTE and two fibrosis scores (Pediatric NAFLD Fibrosis Index and Pediatric NAFLD Fibrosis Score) in the general population aged ≥9 to ≤16 years	2022-2024
Detection and structuring of the variables that constitute a specific biomarker for the paediatric-juvenile population that is capable of accurately determining the presence of hepatic steatosis	2022-2024
Correlation of liver steatosis diagnosis using CAP by VCTE or FLI with the presence of lifestyle and socio-economic factors associated with NAFLD in the general population aged ≥9 to ≤16 years	2022-2024
Percentage of subjects with BMI ≥30 in the general population aged ≥9 to ≤16 years	2022-2024
Percentage of subjects with Metabolic Syndrome according to the International Diabetes Federation (IDF) consensus criteria for children and adolescents in the general population aged ≥9 to ≤16 years.	2022-2024

Collaborators and Investigators

• Sponsor: Jordi Gol i Gurina Foundation
• Collaborators: Fundació Institut Germans Trias i Pujol; Institut d'Investigacions Biomèdiques August Pi i Sunyer; Hospital del Mar Research Institute (IMIM)

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2022
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (ACTUAL): September 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Primary care; Liver fibrosis; Lifestyle; Vibration-Controlled Transient Elastography; Controlled Attenuation Parameter
• Additional Relevant MeSH Terms: Digestive System Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Liver Diseases; Fatty Liver; Pediatric Obesity; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: SLT/21/000047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No