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Clinical Epidemiology of NAFLD in Children and Adolescents

NCT05526274 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2866

Last updated 2022-09-02

No results posted yet for this study

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.

Conditions

  • Non-Alcoholic Fatty Liver Disease
  • Childhood Obesity

Interventions

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.

Sponsors & Collaborators

  • Hospital del Mar Research Institute (IMIM)

    collaborator OTHER

  • Institut d'Investigacions Biomèdiques August Pi i Sunyer

    collaborator OTHER

  • Fundació Institut Germans Trias i Pujol

    collaborator OTHER

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    lead OTHER

Eligibility

Min Age
9 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2023-07-31
Completion
2023-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05526274 on ClinicalTrials.gov