MASLD in Type 2 Diabetes in Primary Care - a Follow-up Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Cirrhosis, Advanced Fibrosis, Sarcopenia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating the Prevalence and Severity of MASLD in Primary Care - a Follow-up Study
Overview
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.
Primary outcome measures
- Prevalence of MASLD [Time frame: 2031]
- Progression/regression of MASLD [Time frame: 2031]
- Predictors of MASLD progression/regression [Time frame: 2031]
- Prevalence of advanced fibrosis [Time frame: 2031]
- Progression/regression of advanced fibrosis [Time frame: 2031]
- Predictors of fibrosis progression/regression [Time frame: 2031]
- The association between physical activity and prevalent advanced fibrosis [Time frame: 2031]
- The association between physical activity and risk of progressing to advanced fibrosis [Time frame: 2031]
- Genetic factors associated with advanced fibrosis or MASLD progression/regression [Time frame: 2031]
- Association between body composition and MASLD and/or liver fibrosis and progression/regression thereof [Time frame: 2031]
Secondary outcome measures (4)
- The association of hypertension and MASLD (with or withour signs of advanced fibrosis) [Time frame: 2031]
- The association between OSAS and MASLD (with or withour advanced fibrosis) [Time frame: 2031]
- Health economic model for disease management [Time frame: 2034]
- Number of patients that develop symptoms of end-stage liver disease [Time frame: 2035]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Department of Gastroenterology and Hepatology, Linköping University Hospital — Linköping
Identifiers
NCT: NCT07312136 · 2024-05471-01