HIBOC = Hepatic Imaging Biomarkers in Obese Children

Not yet recruiting

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

• Registration Number: NCT06463223
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief Summary

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.

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 Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-12
• Last Update Submitted: 2024-06-16
• Study First Posted: 2024-06-17
• Last Update Posted: 2024-06-18
• Study Start: 2024-10
• Primary Completion: 2028-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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