Non-Alcoholic Fatty Liver DiseaseLiverKidsNCT05526274
Clinical Epidemiology of NAFLD in Children and Adolescents
An observational study of Non-Alcoholic Fatty Liver Disease and Childhood Obesity, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 9 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Childhood Obesity
- How many people
- 2,866 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2022to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Subjects with previously diagnosed liver disease.
- Subjects receiving hepatotoxic drug treatment.
- Subjects with diagnosed eating disorders.
Trial locations and contacts
1 site in 1 country.
Spain1 site
IDIAP Jordi Gol i Gurina
Mataró, Barcelona, 08303
Carmen Expósito Martínez, PhD, 93 741 53 38, cexposito.mn.ics@gencat.cat
Carla Chacón Valera, MS, 93 741 53 38, cchaconv.mn.ics@gencat.cat
About this study
Official title: Clinical Epidemiology of Non-alcoholic Fatty Liver Disease in Children and Adolescents. The LiverKids Study.
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.
- Being tested
- Vibration-Controlled Transient Elastography (VCTE) with Controlled Attenuation Parameter (CAP)
- Keywords
- Vibration-Controlled Transient Elastography, Controlled Attenuation Parameter, Lifestyle, Liver fibrosis, Primary care
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Pediatric Obesity, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| General population aged ≥9 to ≤16 years. | Not described Receives: Diagnostic Test: Vibration-Controlled Transient Elastography (VCTE) with Controlled Attenuation Parameter (CAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with LSM ≥6.5 kPa by VCTE in the general population aged ≥9 to ≤16 years
Measured: 2022-2024
Percentage of subjects with CAP ≥225 dB/m by VCTE in the general population aged ≥9 to ≤16 years.
Measured: 2022-2024
Comparison of liver steatosis diagnosis accuracy between CAP by VCTE and MRI in the general population aged ≥9 to ≤16 years.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2022-2024
Percentage of subjects with BMI ≥30 in the general population aged ≥9 to ≤16 years
Measured: 2022-2024
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.
Measured: 2022-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,866 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital del Mar Research Institute (IMIM), Institut d'Investigacions Biomèdiques August Pi i Sunyer, Fundació Institut Germans Trias i Pujol
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526274
- Sponsor's protocol ID
- SLT/21/000047
- Acronym
- LiverKids
- Status last verified
- Aug 2022
- First submitted
- 29 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37831682
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Epidemiology of Non-alcoholic Fatty Liver Disease in Children and Adolescents. The LiverKids Study.
- ClinicalTrials.gov ID
- NCT05526274
- Acronym / sponsor ID
- LiverKids / SLT/21/000047
- Keywords
- Vibration-Controlled Transient Elastography, Controlled Attenuation Parameter, Lifestyle, Liver fibrosis, Primary care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,866 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Hospital del Mar Research Institute (IMIM), Institut d'Investigacions Biomèdiques August Pi i Sunyer, Fundació Institut Germans Trias i Pujol
- Study start
- Oct 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General population aged ≥9 to ≤16 years. | – | Diagnostic Test: Vibration-Controlled Transient Elastography (VCTE) with Controlled Attenuation Parameter (CAP) |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Subjects with previously diagnosed liver disease.
- Subjects receiving hepatotoxic drug treatment.
- Subjects with diagnosed eating disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | General population aged ≥9 to ≤16 years. |
Primary outcome
Percentage of subjects with LSM ≥6.5 kPa by VCTE 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
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
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
6 secondary outcomes
Comparison of liver steatosis diagnosis accuracy between CAP by VCTE and Fatty Liver Index (FLI) in the general population aged ≥9 to ≤16 years
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2022-2024
Percentage of subjects with BMI ≥30 in the general population aged ≥9 to ≤16 years
Time frame: 2022-2024
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.
Time frame: 2022-2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Derived from this study: PubMed 37831682Chacon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease and Childhood Obesity, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carmen Expósito Martínez, PhD (93 741 53 38, cexposito.mn.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with LSM ≥6.5 kPa by VCTE in the general population aged ≥9 to ≤16 years (time frame: 2022-2024). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05526274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.