Ignite Creation Date:
2024-05-06 @ 6:02 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05526274
Status:
UNKNOWN
Last Update Posted:
2022-09-02
First Post:
2022-08-29
Brief Title:
Clinical Epidemiology of NAFLD in Children and Adolescents
Sponsor:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Organization:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Study Overview
Official Title:
Clinical Epidemiology of Non-alcoholic Fatty Liver Disease in Children and Adolescents The LiverKids Study
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LiverKids
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 LSM65kPa using VCTE and that of non-alcoholic fatty liver disease 225dBm 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 2866 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None