Clinical Epidemiology of NAFLD in Children and Adolescents

Non-Alcoholic Fatty Liver Disease Clinical Trial

— LiverKids  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05526274
• Other study ID #: SLT/21/000047
• Status: Not yet recruiting
• Start date: October 2022
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: Jordi Gol i Gurina Foundation
• Contact: Carmen Expósito Martínez, PhD
• Phone: 93 741 53 38
• Email: cexposito.mn.ics[@]gencat.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2866
• Est. completion date: December 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Obesity
• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
Spain	IDIAP Jordi Gol i Gurina	Mataró	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Fundació Institut Germans Trias i Pujol, Hospital del Mar Research Institute (IMIM), Institut d'Investigacions Biomèdiques August Pi i Sunyer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with LSM =6.5 kPa by VCTE in the general population aged =9 to =16 years		2022-2024
Primary	Percentage of subjects with CAP =225 dB/m by VCTE in the general population aged =9 to =16 years.		2022-2024
Primary	Comparison of liver steatosis diagnosis accuracy between CAP by VCTE and MRI in the general population aged =9 to =16 years.		2022-2024
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of subjects with BMI =30 in the general population aged =9 to =16 years		2022-2024
Secondary	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