Evaluating Prevalence and Severity of NAFLD In Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 317
- 试验地点
- 2
- 主要终点
- The association between fitness and advanced liver disease (fibrosis >2)
研究概览
简要总结
The EPSONIP (Evaluating Prevalence and Severity Of NAFLD In Primary care) trial is a longitudinal cohort study of patients with T2DM recruited from primary health care centers in Östergötland, Sweden. The latest MRI techniques will be used to quantify the amount of hepatic fat, inflammation, liver fibrosis and body composition. Each patient will be investigated twice with three years apart to determine patients with progressive disease.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes type 2
- •Age 35-75 year
排除标准
- •Contraindication to MR
- •Alcohol dependance
- •Previously diagnosed liver cirrhosis
- •Previously known liver disease (other than fatty liver)
结局指标
主要结局
The association between fitness and advanced liver disease (fibrosis >2)
时间窗: 2020
Liver fibrosis measured with MRE and liver biopsy. Fitness measured with the six minute walk test.
Prevalence of advanced liver disease
时间窗: 2020
Number of patients with advanced liver disease (fibrosis stage \> 2)
Prevalence of fatty liver
时间窗: 2020
Number of patients with fatty liver measured with MR-PDFF
The association between physical activity and advanced liver disease (fibrosis >2)
时间窗: 2020
Liver fibrosis measured with MRE and liver biopsy. Physical activity measured with Actigraph GT3X (accelerometer)
Genetic factors associated with advanced liver disease (fibrosis >2)
时间窗: 2020
Liver fibrosis measured with MRE and liver biopsy. Genes to be analyzed: PNPLA3, TM6SF2, MBOAT
次要结局
- Health economic model for disease management(2025)
- Number of patients that develop symptoms of end-stage liver disease(2030)
研究者
Mattias Ekstedt
Senior Lecturer/Consultant
Linkoeping University