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Imaging-based Biomarkers for Early Detection of Liver Disease in Children with Obesity

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Study Aim

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.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Body Weight+15

+ Digestive System Diseases

+ Disease

From 9 to 14 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: October 2024
See protocol details

Summary

Principal SponsorSahlgrenska University Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleImaging-based Biomarkers for Liver Disease in Children With Obesity-a Longitudinal Study
NCT06463223
Principal SponsorSahlgrenska University Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Body WeightDigestive System DiseasesDiseaseFatty LiverFibrosisHepatitisLiver CirrhosisLiver DiseasesMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesityPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweightPediatric Obesity

Criteria

4 inclusion criteria required to participate
Age 9 to 14 years

New referral/first visit or follow-up annual visit at each healthcare center (Child and adolescent oriented centers) included

BMI 30 or more

Obesity >1 year at inclusion

4 exclusion criteria prevent from participating
Difficulty understanding written/oral information

Comorbidities that can affect the liver (e.g., medications or diseases with known liver impact)

Claustrophobia (applies to the MRI cohort)

Implants or other factors that prevent MRI (applies to the MRI cohort)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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