HIBOC = Hepatic Imaging Biomarkers in Obese Children

NCT06463223 | Not Yet Recruiting

• 1 other identifier: 2024-02255-01
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Magnetic Resonance Imaging fat fraction

  baseline, 1 year, 2 years and 3 years follow up

• Magnetic Resonance Imaging elastography

  Baseline, 1 year,2 years and 3 years follow up

• Magnetic Resonance Imaging diffusionbased imaging

  baseline, 1 year, 2 years and 3 years follow up

• Magnetic Resonance Imaging relaxometry

  Baseline, 1 year,2 years and 3 years follow up

Other Outcomes (2)

• serology measures

  baseline, 1 year, 2 years and 3 years follow up

• BMI

  baseline, 1 year, 2 years and 3 years follow up

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

MeSH Terms

Conditions

Pediatric Obesity; Metabolic Diseases; Liver Cirrhosis; Disease; Hepatitis; Fatty Liver

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 18, 2024

Record last verified: 2024-06