Evaluating the Prevalence and Severity of MASLD in Primary Care - a Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 317
- 试验地点
- 1
- 主要终点
- Prevalence of MASLD
研究概览
简要总结
The EPSOMIP2 (Evaluating the Prevalence and Severity Of MASLD In Primary care - a Follow-up Study) trial is a longitudinal cohort study of patients with type 2 diabetes recruited from primary health care centers in Östergötland, Sweden. Between 2019-2023, 317 patients were included and underwent rigorous clinical evaluation, vibration controlled transient elastography, biobanking of bloodsamples, and the latest magnetic resonance techniques to liver and body composition. All patients alive will be re-invited to undergo the same evaluation and additional tests.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously included and fulfilled evaluation in EPSONIP trial (NCT03864510)
- •Age >/= 18 years
- •Informed consent
排除标准
- •Contraindication to magnetic resonance
- •Other primary liver disease than MASLD diagnosed after inclusion EPSONIP trial (NCT03864510)
- •Liver transplantation
结局指标
主要结局
Prevalence of MASLD
时间窗: 2031
Number of patients with MASLD measured with MRI-PDFF or CAP
Progression/regression of MASLD
时间窗: 2031
Number of patients who progress/regress to/from MASLD between two timepoints as measured with MRI-PDFF or CAP
Predictors of MASLD progression/regression
时间窗: 2031
Liver fat measured with MRI-PDFF. Predicitive variables collected through clinical evaluation, blood tests, physical activitiy evaluation, OSAS evaluation, hypertension measurements among others.
Prevalence of advanced fibrosis
时间窗: 2031
Number of patients with advanced liver disease as defined by VCTE or MRE (or clinically, i.e., signos of cirrohsis or hepatic decompensation)
Progression/regression of advanced fibrosis
时间窗: 2031
Progression/regression to/from advanced liver disease as measured with VCTE or MRE between two timepoints
Predictors of fibrosis progression/regression
时间窗: 2031
Liver fibrosis measured with MRE or VCTE. Predicitive variables collected through clinical evaluation, blood tests, physical activitiy evaluation, OSAS evaluation, hypertension measurements among others.
The association between physical activity and prevalent advanced fibrosis
时间窗: 2031
Liver fibrosis measured with VCTE or MRE. Physical activity measured with the international fitness scale (IFIS) and/or Actigraph GT3X (accelerometer).
The association between physical activity and risk of progressing to advanced fibrosis
时间窗: 2031
Liver fibrosis measured with MRE or VCTE. Physical activity measured with the international fitness scale (IFIS) and/or Actigraph GT3X (accelerometer).
Genetic factors associated with advanced fibrosis or MASLD progression/regression
时间窗: 2031
Liver fibrosis measured with MRE and VCTE. Liver fat measured with MRI-PDFF and CAP. Genes to be analyzed: PNPLA3, TM6SF2, MBOAT among others.
Association between body composition and MASLD and/or liver fibrosis and progression/regression thereof
时间窗: 2031
Liver fat measured with MRI-PDFF or CAP. Liver fibrosis measured with MRE or VCTE. Body composition measured with AMRA Medical AB's MAsS Scan.
次要结局
- The association of hypertension and MASLD (with or withour signs of advanced fibrosis)(2031)
- The association between OSAS and MASLD (with or withour advanced fibrosis)(2031)
- Health economic model for disease management(2034)
- Number of patients that develop symptoms of end-stage liver disease(2035)
研究者
Patrik Nasr
Adj Associate Professor, Docent, Specialist doctor
Linkoeping University