Clinical Epidemiology of NAFLD in Children and Adolescents

NCT05526274 | Unknown DMC

• 1 other identifier: SLT/21/000047
• Study Type: observational
• Target: 2,866
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Fatty Liver Disease; Childhood Obesity

Keywords

Vibration-Controlled Transient Elastography; Controlled Attenuation Parameter; Lifestyle; Liver fibrosis; Primary care

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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

Study Arms (1)

General population aged ≥9 to ≤16 years.

Diagnostic Test: Vibration-Controlled Transient Elastography (VCTE) with Controlled Attenuation Parameter (CAP)

Interventions

Vibration-Controlled Transient Elastography (VCTE) with Controlled Attenuation Parameter (CAP) DIAGNOSTIC_TEST

VCTE with associated CAP is an effective, non-invasive and safe diagnostic method to estimate the degree of fibrosis and steatosis in the liver.

General population aged ≥9 to ≤16 years.

Eligibility Criteria

• Age: 9 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Hospital del Mar Research Institute (IMIM): collaborator
• Institut d'Investigacions Biomèdiques August Pi i Sunyer: collaborator
• Fundació Institut Germans Trias i Pujol: collaborator

Study Sites (1)

IDIAP Jordi Gol i Gurina

Mataró, Barcelona, 08303, Spain

Location

Related Publications (1)

• Chacon C, Arteaga I, Martinez-Escude A, Ruiz Rojano I, Lamonja-Vicente N, Caballeria L, Ribatallada Diez AM, Schroder H, Montraveta M, Bovo MV, Gines P, Pera G, Diez-Fadrique G, Pachon-Camacho A, Alonso N, Graupera I, Toran-Monserrat P, Exposito C. Clinical epidemiology of non-alcoholic fatty liver disease in children and adolescents. The LiverKids: Study protocol. PLoS One. 2023 Oct 13;18(10):e0286586. doi: 10.1371/journal.pone.0286586. eCollection 2023.

  PMID: 37831682 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Analytical determination will be performed on all subjects, after 12 hours of fasting, at the Primary Care Centre. It will include: 1. blood count, glucose, glycosylated haemoglobin, basal insulin levels, total cholesterol, high-density lipoprotein(HDL-cholesterol), low-density lipoprotein(LDL-cholesterol), triglycerides(TG), transaminases (AST, ALT), gamma-glutamyl-transpeptidase(GGT), alkaline phosphatase, total bilirubin, sideremia, transferrin, transferrin saturation index, total protein, albumin, urea, creatinine, sodium, potassium, TSH and T4. 2. Determination of insulin resistance using the HOMA method: blood glucose(mmol/L) x insulin(mU/L)/22,5.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Pediatric Obesity; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fibrosis; Pathologic Processes

Central Study Contacts

Carmen Expósito Martínez, PhD

CONTACT

93 741 53 38; cexposito.mn.ics@gencat.cat

Carla Chacón Valera, MS

CONTACT

93 741 53 38; cchaconv.mn.ics@gencat.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 2, 2022
• Study Start: October 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)