Comparison Between the Efficacy of Residential and Ambulatory Weight Loss Programs for Pediatric Non-alcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 850
- 试验地点
- 3
- 主要终点
- Improvement of liver fibrosis
研究概览
简要总结
Non-alcoholic fatty liver disease (NAFLD) has become the most prevalent chronic liver disease worldwide, paralleling the obesity pandemic. Secondary to increasing rates of obesity in children and adolescents, the prevalence of NAFLD has more than doubled in the last decades and is now the most common pediatric liver disease.
At present, lifestyle modification by dietary intervention and increasing physical activity is the mainstay of treatment for pediatric NAFLD. Several studies have shown that lifestyle intervention and weight loss improve non-invasive markers of NAFLD. To the investigator's knowledge, data on fibrosis regression following lifestyle treatment in children and adolescents were lacking. The investigators therefore performed a prospective cohort study to investigate the impact of residential lifestyle treatment on liver steatosis and fibrosis in obese children and adolescents.
As a follow-up, the investigators now aim to compare these findings with a cohort of well-characterized patients undergoing multidisciplinary, yet ambulatory, weight loss treatment. As such, the investigators will compare the outcomes in two prospective patient cohorts in this non-randomized observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in the lifestyle management program for obesity in one of the participating centres
排除标准
- •Syndromic obesity
- •Evidence of liver disease of other causes (viral, auto-immune, genetic)
- •Average daily alcohol consumption of >20g/day
- •Unvalid screening Fibroscan
- •Treatment with drugs which can induce liver steatosis or fibrosis (e.g. systemic corticosteroids, methotrexate)
结局指标
主要结局
Improvement of liver fibrosis
时间窗: 6 months of lifestyle intervention
Liver fibrosis will be quantified using Fibroscan, and patients will be divided into disease stages based on published cut-offs.
次要结局
- Improvement in ALT(12 months of lifestyle intervention)
- Improvement of liver fibrosis(12 months of lifestyle intervention)
- Resolution of liver steatosis(12 months of lifestyle intervention)
- Improvement of liver steatosis(12 months of lifestyle intervention)
- Resolution of liver fibrosis(12 months of lifestyle intervention)