Clinical trial

MASLD in Type 2 Diabetes in Primary Care - a Follow-up Study

Invitation only · Not applicable · 1 countries · Registry ID NCT07312136

Invitation onlyNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionMASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Cirrhosis, Advanced Fibrosis, Sarcopenia, Obesity & Overweight, Type 2 Diabetes, Hypertension, OSAS (Obstructive Sleep Apneas Syndrome), Metabolic Syndrome

Full registry 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

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Prevalence of MASLD2031

Number of patients with MASLD measured with MRI-PDFF or CAP

Progression/regression of MASLD2031

Number of patients who progress/regress to/from MASLD between two timepoints as measured with MRI-PDFF or CAP

Predictors of MASLD progression/regression2031

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 fibrosis2031

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 fibrosis2031

Progression/regression to/from advanced liver disease as measured with VCTE or MRE between two timepoints

Predictors of fibrosis progression/regression2031

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 fibrosis2031

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 fibrosis2031

Liver fibrosis measured with MRE or VCTE. Physical activity measured with the international fitness scale (IFIS) and/or Actigraph GT3X (accelerometer).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Department of Gastroenterology and Hepatology, Linköping University Hospital🇸🇪 Linköping, Östergötland County, Sweden

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