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.
Study Type
OBSERVATIONAL
Enrollment
317
Department of Gastroenterology and Hepatology, Linköping University Hospital
Linköping, Östergötland County, Sweden
Prevalence of MASLD
Number of patients with MASLD measured with MRI-PDFF or CAP
Time frame: 2031
Progression/regression of MASLD
Number of patients who progress/regress to/from MASLD between two timepoints as measured with MRI-PDFF or CAP
Time frame: 2031
Predictors of MASLD progression/regression
Liver fat measured with MRI-PDFF. Predicitive variables collected through clinical evaluation, blood tests, physical activitiy evaluation, OSAS evaluation, hypertension measurements among others.
Time frame: 2031
Prevalence of advanced fibrosis
Number of patients with advanced liver disease as defined by VCTE or MRE (or clinically, i.e., signos of cirrohsis or hepatic decompensation)
Time frame: 2031
Progression/regression of advanced fibrosis
Progression/regression to/from advanced liver disease as measured with VCTE or MRE between two timepoints
Time frame: 2031
Predictors of fibrosis progression/regression
Liver fibrosis measured with MRE or VCTE. Predicitive variables collected through clinical evaluation, blood tests, physical activitiy evaluation, OSAS evaluation, hypertension measurements among others.
Time frame: 2031
The association between physical activity and prevalent advanced fibrosis
Liver fibrosis measured with VCTE or MRE. Physical activity measured with the international fitness scale (IFIS) and/or Actigraph GT3X (accelerometer).
Time frame: 2031
The association between physical activity and risk of progressing to advanced fibrosis
Liver fibrosis measured with MRE or VCTE. Physical activity measured with the international fitness scale (IFIS) and/or Actigraph GT3X (accelerometer).
Time frame: 2031
Genetic factors associated with advanced fibrosis or MASLD progression/regression
Liver fibrosis measured with MRE and VCTE. Liver fat measured with MRI-PDFF and CAP. Genes to be analyzed: PNPLA3, TM6SF2, MBOAT among others.
Time frame: 2031
Association between body composition and MASLD and/or liver fibrosis and progression/regression thereof
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.
Time frame: 2031
The association of hypertension and MASLD (with or withour signs of advanced fibrosis)
Liver fibrosis measured with MRE or VCTE. Hypertension measured with weekly blood pressure measurement and/or 24 hour blood pressure measurement.
Time frame: 2031
The association between OSAS and MASLD (with or withour advanced fibrosis)
Liver fat measured with MRI-PDFF or CAP. Liver fibrosis measured with VCTE or MRE. OSAS measured at university hospital sleep apnea.
Time frame: 2031
Health economic model for disease management
Markov modelling
Time frame: 2034
Number of patients that develop symptoms of end-stage liver disease
Symptoms of end-stage liver disease (ascites, encepahopathy, varices, HCC) or liver related Death will be recorded through chart review
Time frame: 2035
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