Ignite Creation Date:
2024-07-17 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463223
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-12
Brief Title:
HIBOC Hepatic Imaging Biomarkers in Obese Children
Sponsor:
Sahlgrenska University Hospital Sweden
Organization:
Sahlgrenska University Hospital Sweden
Study Overview
Official Title:
Imaging-based Biomarkers for Liver Disease in Children With Obesity-a Longitudinal Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 fibrosisinflammationsteatosis without a biopsy it is possible to monitor the disease more rigorously which opens new opportunities to optimize treatment for the individual child
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 fibrosisinflammationsteatosis without a biopsy it is possible to monitor the disease more rigorously which opens new opportunities to optimize treatment for the individual child
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None