Clinical Epidemiology of Non-alcoholic Fatty Liver Disease in Children and Adolescents. The LiverKids Study.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 2,866
- Locations
- 1
- Primary Endpoint
- Percentage of subjects with LSM ≥6.5 kPa by VCTE in the general population aged ≥9 to ≤16 years
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 9 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Percentage of subjects with LSM ≥6.5 kPa by VCTE in the general population aged ≥9 to ≤16 years
Time Frame: 2022-2024
Comparison of liver steatosis diagnosis accuracy between CAP by VCTE and MRI in the general population aged ≥9 to ≤16 years.
Time Frame: 2022-2024
Percentage of subjects with CAP ≥225 dB/m by VCTE in the general population aged ≥9 to ≤16 years.
Time Frame: 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.
Time Frame: 2022-2024
Secondary Outcomes
- 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)
- 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)
- 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)
- 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)
- 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)