HIBOC = Hepatic Imaging Biomarkers in Obese Children

Metabolic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06463223
• Other study ID #: 2024-02255-01
• Status: Not yet recruiting
• Start date: October 2024
• Est. completion date: December 2029

Study information

• Verified date: June 2024
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2029
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 14 Years

Eligibility

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)

Related Conditions & MeSH terms

• Child Obesity
• Diagnosis
• Elastography
• Fibrosis, Liver
• Genetic Diseases, Inborn
• Hepatitis
• Inflammation
• Liver Cirrhosis
• Metabolic Disease
• Metabolic Diseases
• Obesity
• Pediatric Obesity
• Steatosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	serology measures	blood work	baseline, 1 year, 2 years and 3 years follow up
Other	BMI	body mass index	baseline, 1 year, 2 years and 3 years follow up
Primary	Attenuation imaging	an ultrasound based measure of steatosis in the liver	baseline, 1 year, 2 years and 3 years follow up
Primary	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
Primary	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	Magnetic Resonance Imaging fat fraction	Estimation of fat content in the liver	baseline, 1 year, 2 years and 3 years follow up
Secondary	Magnetic Resonance Imaging elastography	measurement of liver stiffnes on MRI	Baseline, 1 year,2 years and 3 years follow up
Secondary	Magnetic Resonance Imaging diffusionbased imaging	Quantitative estimation of viscoelastic tissue properties	baseline, 1 year, 2 years and 3 years follow up
Secondary	Magnetic Resonance Imaging relaxometry	Detailed tissue characterization with measurement of fibrosis in the liver	Baseline, 1 year,2 years and 3 years follow up