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

December 16, 2025 updated by: Patrik Nasr, Linkoeping University

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
317

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence of MASLD
Time Frame: 2031
Number of patients with MASLD measured with MRI-PDFF or CAP
2031
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
2031
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.
2031
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)
2031
Progression/regression of advanced fibrosis
Time Frame: 2031
Progression/regression to/from advanced liver disease as measured with VCTE or MRE between two timepoints
2031
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.
2031
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).
2031
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).
2031
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.
2031
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.
2031

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
2031
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.
2031
Health economic model for disease management
Time Frame: 2034
Markov modelling
2034
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
2035

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Linkoeping University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Linkoeping
Amra Medical AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 16, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2034

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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