Imaging-based Biomarkers for Early Detection of Liver Disease in Children with Obesity
This study aims to observe and measure various ultrasound-based indicators, such as liver stiffness, fat content, and viscosity, in children with obesity to aid in the early detection of liver disease.
Data Collection
Collected from today forward - ProspectiveBody Weight+15
+ Digestive System Diseases
+ Disease
Other
Utilizing specific methods not covered by standard models in order to address unique research questions.Summary
Study start date: October 1, 2024
Actual date on which the first participant was enrolled.Childhood obesity is a growing health concern worldwide, with 10% of children affected. This condition often leads to a type of liver disease known as metabolic-associated fatty liver disease (MAFLD), which can range from fatty liver to more serious conditions like hepatitis, fibrosis, and even cancer. Early detection is key to reducing the impact of these conditions, but traditionally, this has required invasive liver biopsies. This study focuses on children aged 9-14 years with a BMI greater than 29 and obesity lasting over a year, aiming to find a less invasive way to diagnose liver disease. The study's goal is to improve diagnostics for liver disease in children with obesity, potentially leading to better care and treatment outcomes. The study uses non-invasive imaging markers, specifically ultrasound and MRI, to assess liver health. These markers include Shear Wave Dispersion (SWD), Shear Wave Elastography (SWE), and Attenuation Imaging (ATI), which reflect inflammation, fibrosis, and steatosis in the liver, respectively. Participants will undergo ultrasound measurements of these markers at the start of the study and during annual visits over three years. These results will then be compared with other clinical measures like weight, height, BMI, blood tests, and more. For a smaller group of about 50 children, MRI scans will also be performed. The hope is that these imaging markers can accurately diagnose liver disease before it becomes severe, and distinguish between different types of liver conditions without needing a biopsy. This could lead to more rigorous disease monitoring and better individualized treatment for children with obesity-related liver disease.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 9 to 14 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives