Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07312136

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease Advanced Fibrosis Apnea Atrophy Body Weight Cardiovascular Diseases Cirrhosis Diabetes Mellitus Diabetes Mellitus, Type 2 Dyssomnias Endocrine System Diseases Fibrosis Glucose Metabolism Disorders Hyperinsulinism Hypertension Insulin Resistance Metabolic Diseases Metabolic Syndrome Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases OSAS (Obstructive Sleep Apneas Syndrome) Obesity Obesity & Overweight Overnutrition Overweight Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sarcopenia Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Type 2 Diabetes Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastroenterology and Hepatology, Linköping University Hospital

Linköping, Östergötland County, 58185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of MASLD

    Time frame: 2031

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

  2. Progression/regression of MASLD

    Time frame: 2031

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

  3. Predictors of MASLD progression/regression

    Time frame: 2031

    Liver fat measured with MRI-PDFF. Predicitive variables collected through clinical evaluation, blood tests, physical activitiy evaluation, OSAS evaluation, hypertension measurements among others.

  4. Prevalence of advanced fibrosis

    Time frame: 2031

    Number of patients with advanced liver disease as defined by VCTE or MRE (or clinically, i.e., signos of cirrohsis or hepatic decompensation)

  5. Progression/regression of advanced fibrosis

    Time frame: 2031

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

  6. Predictors of fibrosis progression/regression

    Time frame: 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.

  7. The association between physical activity and prevalent advanced fibrosis

    Time frame: 2031

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

  8. The association between physical activity and risk of progressing to advanced fibrosis

    Time frame: 2031

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

  9. Genetic factors associated with advanced fibrosis or MASLD progression/regression

    Time frame: 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.

  10. Association between body composition and MASLD and/or liver fibrosis and progression/regression thereof

    Time frame: 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.

Secondary outcomes

  1. The association of hypertension and MASLD (with or withour signs of advanced fibrosis)

    Time frame: 2031

    Liver fibrosis measured with MRE or VCTE. Hypertension measured with weekly blood pressure measurement and/or 24 hour blood pressure measurement.

  2. The association between OSAS and MASLD (with or withour advanced fibrosis)

    Time frame: 2031

    Liver fat measured with MRI-PDFF or CAP. Liver fibrosis measured with VCTE or MRE. OSAS measured at university hospital sleep apnea.

  3. Health economic model for disease management

    Time frame: 2034

    Markov modelling

  4. Number of patients that develop symptoms of end-stage liver disease

    Time frame: 2035

    Symptoms of end-stage liver disease (ascites, encepahopathy, varices, HCC) or liver related Death will be recorded through chart review

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • Amra Medical AB
  • University Hospital, Linkoeping

Registry information

Official study title

Evaluating the Prevalence and Severity of MASLD in Primary Care - a Follow-up Study

Acronym: EPSOMIP2

Important dates

Study start
2025
Primary completion
2031
Study completion
2034
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.