An observational study in Elastography, Shear Wave Elastography and Shear Wave Dispersion, sponsored by Sahlgrenska University Hospital. Enrolling by invitation at 1 site in Sweden. Open to participants aged 9 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Sahlgrenska University Hospital · Observational
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.
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.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's planned enrollment of 300 is above the median of 180 across 235 observational studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Sahlgrenska University Hospital is the lead sponsor of 263 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Attenuation imaging
an ultrasound based measure of steatosis in the liver
Time frame: 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
Time frame: 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
Time frame: baseline, 1 year, 2 years and 3 years follow up
Magnetic Resonance Imaging fat fraction
Estimation of fat content in the liver
Time frame: baseline, 1 year, 2 years and 3 years follow up
Magnetic Resonance Imaging elastography
measurement of liver stiffnes on MRI
Time frame: Baseline, 1 year,2 years and 3 years follow up
Magnetic Resonance Imaging diffusionbased imaging
Quantitative estimation of viscoelastic tissue properties
Time frame: baseline, 1 year, 2 years and 3 years follow up
Magnetic Resonance Imaging relaxometry
Detailed tissue characterization with measurement of fibrosis in the liver
Time frame: Baseline, 1 year,2 years and 3 years follow up
serology measures
blood work
Time frame: baseline, 1 year, 2 years and 3 years follow up
BMI
body mass index
Time frame: baseline, 1 year, 2 years and 3 years follow up
Started Feb 2025 (actual). Primary completion is estimated for Dec 2029, 58 months after the start.
Of 94 non-industry observational studies under Pediatric Obesity, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 132. This study's planned 58 months is above that.
Counting every sponsor, half of 96 studies reached it within 52 months; a quarter within 21 and three quarters within 132.
How these figures are worked out, and which studies are left out of them.
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