HIBOC = Hepatic Imaging Biomarkers in Obese Children

Imaging-based Biomarkers for Liver Disease in Children With Obesity-a Longitudinal Study

The goal of this prospective, diagnostic observational study is to learn about how imaging based markers for components of liver disease appear in children with obesity. It aims to determine whether the imaging markers (ultrasound and MRI) for liver disease can be tools to improve diagnostics for liver affection in children with obesity and to ascertain how the markers are related to multiple clinical measures, for example BMI and serology measure, and treatment effects over time.

Study Overview

• Status: Enrolling by invitation
• Conditions: Fibrosis, Liver; Steatosis; Elastography; Diagnosis; Child Obesity; Metabolic Disease; Shear Wave Elastography; Shear Wave Dispersion; Attenuation Imaging; Metabolic and Genetic Disorder Affecting the Liver; Inflammation; Liver

Detailed Description

Background Childhood obesity is a global health problem with a prevalence of 10%. Overweight and obesity are strongly associated with metabolic-associated fatty liver disease (MASLD), which includes a continuum of fatty liver, hepatitis, fibrosis, and cancer. Early diagnosis is crucial for reducing morbidity and mortality but requires detailed characterization of the liver, for which invasive biopsies are the gold standard.

New ultrasound-based markers are promising, non-invasive methods for liver characterization; Shear Wave Dispersion (SWD), Shear Wave Elastography (SWE), and Attenuation Imaging (ATI) have been reported as promising for reflecting inflammation, fibrosis, and steatosis in the liver, respectively. Clinical studies are needed to validate the usefulness of these markers, particularly in children.

Purpose The study aims to determine whether imaging markers (ultrasound and MRI) for liver disease can be tools to improve diagnostics for liver affection in children with obesity and to ascertain how the markers are related to multiple clinical measures, for example BMI and serology measures, and treatment effects over time.

Material & Method This study is a prospective diagnostic observational study, including children (approximately 300) referred for obesity to several Pediatric Clinics in Västra Götaland, Sweden. Inclusion criteria are: age 9-14 years, BMI > 29, obesity > 1 year. Exclusion criteria: comorbidity that can affect the liver. Ultrasound with measurements of the livermarkers SWE, SWD, and ATI will be performed at inclusion and during annual visits over 3 years. SWE, SWD, and ATI will be compared with parameters included in clinical monitoring, such as weight, height, BMI, blood tests, blood pressure, waist circumference, physical activity, screen habits, etc. In a subcohort, estimated 50 children, with obesity-related disease as indication for referral and treatment to Queen Silvias Childrens Hospital, additionally MRI will be performed at inclusion.

Significance Imaging-based liver markers have great potential to improve diagnostics in children with obesity by reflecting liver disease without a biopsy. If these markers can be used to early diagnose liver disease before it becomes manifest, it is a significant gain. Additionally, if it is possible to distinguish between different pathoanatomical phenotypes (fibrosis/inflammation/steatosis) without a biopsy, it is possible to monitor the disease more rigorously, which opens new opportunities to optimize treatment for the individual child.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• Sweden
  • Västra Götaland County
    • Gothenburg, Västra Götaland County, Sweden, 41650
      • Department of Radiology, Queen Silvias Children´s Hospital, Institution of Clinical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Prospectively, children referred for obesity to one of several Pediatric and Youth Clinics in the Västra Götaland region will be included. Inclusion in the study will occur via the respective clinic according to the following criteria: age 9 to 14 years, new visit or follow-up annual visit at the respective clinic, BMI of 30 or more, obesity for more than 1 year at the time of inclusion. Exclusion criteria include: difficulties in understanding written/oral information, comorbidity 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).

We aim to include 300 children

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attenuation imaging	an ultrasound based measure of steatosis in the liver	baseline, 1 year, 2 years and 3 years follow up
Shear wave dispersion	an ultrasound based estimation of increased liver viscosity, seen in for example inflammation	baseline, 1 year, 2 years and 3 years follow up
shear wave dispersion	an ultrasound based measure of liver stiffness as a reflection of liver fibrosis	baseline, 1 year, 2 years and 3 years follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnetic Resonance Imaging elastography	measurement of liver stiffnes on MRI	Baseline, 1 year,2 years and 3 years follow up
Magnetic Resonance Imaging fat fraction	Estimation of fat content in the liver	baseline, 1 year, 2 years and 3 years follow up
Magnetic Resonance Imaging diffusionbased imaging	Quantitative estimation of viscoelastic tissue properties	baseline, 1 year, 2 years and 3 years follow up
Magnetic Resonance Imaging relaxometry	Detailed tissue characterization with measurement of fibrosis in the liver	Baseline, 1 year,2 years and 3 years follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
serology measures	blood work	baseline, 1 year, 2 years and 3 years follow up
BMI	body mass index	baseline, 1 year, 2 years and 3 years follow up

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Overnutrition; Body Weight; Digestive System Diseases; Liver Diseases; Overweight; Obesity; Fibrosis; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Hepatitis; Disease; Fatty Liver; Liver Cirrhosis; Pediatric Obesity; Metabolic Diseases
• Other Study ID Numbers: 2024-02255-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No