Clinical trial NCT05526274: Clinical Epidemiology of NAFLD in Children and Adolescents
Official title: Clinical Epidemiology of Non-alcoholic Fatty Liver Disease in Children and Adolescents. The LiverKids Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Alcoholic Fatty Liver Disease
Childhood Obesity
Keywords: Vibration-Controlled Transient Elastography
Controlled Attenuation Parameter
Lifestyle
Liver fibrosis
Primary care
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Hospital del Mar Research Institute (IMIM)
name: Institut d'Investigacions Biomèdiques August Pi i Sunyer
name: Fundació Institut Germans Trias i Pujol
First posted: 2022-09-02
Enrollment: 2866
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of subjects with LSM ≥6.5 kPa by VCTE in the general population aged ≥9 to ≤16 years
timeFrame: 2022-2024
measure: Percentage of subjects with CAP ≥225 dB/m by VCTE in the general population aged ≥9 to ≤16 years.
timeFrame: 2022-2024
measure: Comparison of liver steatosis diagnosis accuracy between CAP by VCTE and MRI in the general population aged ≥9 to ≤16 years.
timeFrame: 2022-2024
measure: Determination of optimal cut-off points of the CAP for the diagnosis of mild, moderate and severe liver steatosis in children and adolescents.
timeFrame: 2022-2024
Secondary outcomes:
measure: Comparison of liver steatosis diagnosis accuracy between CAP by VCTE and Fatty Liver Index (FLI) in the general population aged ≥9 to ≤16 years
timeFrame: 2022-2024
measure: 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
timeFrame: 2022-2024
measure: 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
timeFrame: 2022-2024
measure: 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
timeFrame: 2022-2024
measure: Percentage of subjects with BMI ≥30 in the general population aged ≥9 to ≤16 years
timeFrame: 2022-2024
measure: 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.
timeFrame: 2022-2024
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: IDIAP Jordi Gol i Gurina
state: Barcelona
Study officials:
References: