Imaging-based Biomarkers for Liver Disease in Children With Obesity-a Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Attenuation imaging
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Attenuation imaging
时间窗: baseline, 1 year, 2 years and 3 years follow up
an ultrasound based measure of steatosis in the liver
Shear wave dispersion
时间窗: 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
时间窗: baseline, 1 year, 2 years and 3 years follow up
an ultrasound based measure of liver stiffness as a reflection of liver fibrosis
次要结局
- Magnetic Resonance Imaging diffusionbased imaging(baseline, 1 year, 2 years and 3 years follow up)
- 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 relaxometry(Baseline, 1 year,2 years and 3 years follow up)
研究者
Hannah Hebelka
MD, Associate Professor
Sahlgrenska University Hospital