MASLD in Type 2 Diabetes in Primary Care - a Follow-up Study (EPSOMIP2)

Evaluating the Prevalence and Severity of MASLD 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hypertension; Metabolic Syndrome; Type 2 Diabetes; Cirrhosis; Sarcopenia; Advanced Fibrosis; Obesity & Overweight; OSAS (Obstructive Sleep Apneas Syndrome); MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

• Study Type: Observational
• Enrollment (Estimated): 317

Contacts and Locations

Study Locations

• Sweden
  • Östergötland County
    • Linköping, Östergötland County, Sweden, 58185
      • Department of Gastroenterology and Hepatology, Linköping University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who where previously included, and fulfilled participation, in the EPSONIP trial (NCT03864510) between 2019 and 2023 are re-invited to fulfill the same evaluation with additional tests.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of MASLD	Number of patients with MASLD measured with MRI-PDFF or CAP	2031
Progression/regression of MASLD	Number of patients who progress/regress to/from MASLD between two timepoints as measured with MRI-PDFF or CAP	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.	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)	2031
Progression/regression of advanced fibrosis	Progression/regression to/from advanced liver disease as measured with VCTE or MRE between two timepoints	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.	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).	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).	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.	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.	2031

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	2031
Health economic model for disease management	Markov modelling	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	2035

Collaborators and Investigators

• Sponsor: Linkoeping University
• Collaborators: University Hospital, Linkoeping; Amra Medical AB
• Investigators: Principal Investigator: Patrik Nasr, M.D., Ph.D., Department of Health, Medicine and Caring Sciences, Linköping University, and Department of Gastroenterology and Hepatology, Linköping University Hospital, Linköping, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2034

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; MRE; Fibroscan; PDFF; MASLD
• Additional Relevant MeSH Terms: Neurologic Manifestations; Endocrine System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neuromuscular Manifestations; Pathologic Processes; Nutrition Disorders; Pathological Conditions, Anatomical; Metabolic Diseases; Overnutrition; Body Weight; Respiratory Tract Diseases; Respiration Disorders; Glucose Metabolism Disorders; Diabetes Mellitus; Sleep Wake Disorders; Insulin Resistance; Hyperinsulinism; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Hypertension; Diabetes Mellitus, Type 2; Metabolic Syndrome; Fibrosis; Sleep Apnea, Obstructive; Sarcopenia
• Other Study ID Numbers: 2024-05471-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No