Advanced Fibrosis, Cirrhosis, Hypertension, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Syndrome, Obesity & Overweight, OSAS (Obstructive Sleep Apneas Syndrome), Sarcopenia, Type 2 Diabetes
Conditions
Keywords
MASLD, Fibroscan, PDFF, MRE, Obesity
Brief summary
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.
Interventions
None listed
Sponsors
University Hospital, Linkoeping
Amra Medical AB
Linkoeping University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previously included and fulfilled evaluation in EPSONIP trial (NCT03864510) * Age \>/= 18 years * Informed consent
Exclusion criteria
* Contraindication to magnetic resonance * Other primary liver disease than MASLD diagnosed after inclusion EPSONIP trial (NCT03864510) * Liver transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association between body composition and MASLD and/or liver fibrosis and progression/regression thereof | 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. |
| Predictors of fibrosis progression/regression | 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 | 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 | 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 | 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. |
| Prevalence of MASLD | 2031 | Number of patients with MASLD measured with MRI-PDFF or CAP |
| Progression/regression of MASLD | 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 | 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 | 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 | 2031 | Progression/regression to/from advanced liver disease as measured with VCTE or MRE between two timepoints |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The association between OSAS and MASLD (with or withour advanced fibrosis) | 2031 | Liver fat measured with MRI-PDFF or CAP. Liver fibrosis measured with VCTE or MRE. OSAS measured at university hospital sleep apnea. |
| Health economic model for disease management | 2034 | Markov modelling |
| Number of patients that develop symptoms of end-stage liver disease | 2035 | Symptoms of end-stage liver disease (ascites, encepahopathy, varices, HCC) or liver related Death will be recorded through chart review |
| The association of hypertension and MASLD (with or withour signs of advanced fibrosis) | 2031 | Liver fibrosis measured with MRE or VCTE. Hypertension measured with weekly blood pressure measurement and/or 24 hour blood pressure measurement. |
Countries
Sweden
Outcome results
None listed