MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseEPSOMIP2NCT07312136
MASLD in Type 2 Diabetes in Primary Care - a Follow-up Study
An observational study of MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and Cirrhosis, run by Linkoeping University at 1 site in Sweden.
Trial summary
The goal of this observational study is to understand how metabolic dysfunction-associated steatotic liver disease (MASLD) changes over time in individuals with type 2 diabetes who previously participated in the EPSONIP study. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Cirrhosis, Advanced Fibrosis
- How many people
- 317 participants
- Where
- 1 siteSweden
- Study dates
- 16 Dec 2025to 31 Dec 2034
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who where previously included, and completed the assessments in the EPSONIP study (NCT03864510) between 2019 and 2023 are re-invited to fulfill the same evaluation with additional tests.
Who may be able to join
- Previously included and completed the assessments in the EPSONIP study (NCT03864510)
- Age >/= 18 years
- Informed consent
Who cannot join
- Contraindication to magnetic resonance imaging
- Other primary liver disease than MASLD diagnosed after inclusion in the EPSONIP study (NCT03864510)
- Liver transplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Department of Gastroenterology and Hepatology, Linköping University Hospital
Linköping, Östergötland County, 58185
About this study
Official title: Evaluating the Prevalence and Severity of MASLD in Primary Care - a Follow-up Study
The goal of this observational study is to understand how metabolic dysfunction-associated steatotic liver disease (MASLD) changes over time in individuals with type 2 diabetes who previously participated in the EPSONIP study.
The main questions it aims to answer are:
Read more
- How common are MASLD and advanced liver fibrosis at long-term follow-up?
- Which factors are associated with progression or regression of liver fat accumulation and liver fibrosis over time?
Participants will:
- Undergo a clinical examination and review of medical history.
- Provide blood, urine, and biobank samples.
- Undergo liver assessment using vibration-controlled transient elastography (VCTE).
- Undergo magnetic resonance imaging (MRI) to assess liver fat, liver fibrosis, and body composition.
- Complete questionnaires regarding lifestyle and physical activity.
- Undergo physical activity measurements using accelerometers and additional assessments related to blood pressure and sleep apnea.
Read the detailed description
Metabolic dysfunction-associated steatotic liver disease (MASLD) is one of the most common chronic liver diseases worldwide and is particularly common among individuals with type 2 diabetes. While many people remain stable over time, some develop progressive liver fibrosis, cirrhosis, hepatocellular carcinoma, and other serious liver-related complications. Reliable methods for identifying patients at greatest risk of disease progression remain limited.
EPSOMIP2 is a prospective observational follow-up study of participants who were previously enrolled in the EPSONIP study (NCT03864510) between 2019 and 2023. In the original study, 317 individuals with type 2 diabetes from primary healthcare centers in Östergötland, Sweden, underwent detailed evaluation of liver disease, metabolic health, physical activity, and body composition.
Participants who completed the original study are invited to undergo a new assessment approximately 6 years after their initial evaluation. The follow-up examination includes clinical assessment, blood and urine sampling, vibration-controlled transient elastography, magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF), magnetic resonance elastography (MRE), body composition analysis, questionnaires, physical activity measurements, blood pressure assessments, and biobanking.
By comparing the follow-up findings with data collected during the original EPSONIP study, researchers aim to characterize the long-term natural history of MASLD in type 2 diabetes. The study will evaluate prevalence, progression, and regression of hepatic steatosis and liver fibrosis, and investigate associations with physical activity, body composition, genetic variants, hypertension, obstructive sleep apnea, and other metabolic risk factors.
The study will also investigate the occurrence of clinically significant liver-related outcomes, including decompensated liver disease, hepatocellular carcinoma, liver transplantation, and liver-related mortality. In addition, health-economic analyses will be performed to evaluate strategies for MASLD management and risk stratification.
The overall aim of EPSOMIP2 is to improve understanding of the long-term course of MASLD in individuals with type 2 diabetes and to identify factors associated with progression to advanced liver disease.
- Conditions
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Cirrhosis, Advanced Fibrosis, Sarcopenia, Obesity & Overweight, Type 2 Diabetes
- Keywords
- MASLD, Fibroscan, PDFF, MRE, Obesity, VCTE
- Medical subject headings
- Fibrosis, Sarcopenia, Obesity, Overweight, Diabetes Mellitus, Type 2, Hypertension, Sleep Apnea, Obstructive, Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of MASLD (MRI-PDFF)
Number of patients with MASLD measured with MRI-PDFF
Measured: From December 2025 to December 2031
Prevalence of MASLD (CAP)
Number of patients with MASLD measured with CAP
Measured: From December 2025 to December 2031
Progression/regression of MASLD (MRI-PDFF)
Number of patients who progress/regress to/from MASLD between two timepoints as measured with MRI-PDFF
Measured: From December 2025 to December 2031
Progression/regression of MASLD (CAP)
Number of patients who progress/regress to/from MASLD between two timepoints as measured with CAP
Measured: From December 2025 to December 2031
Prevalence of advanced fibrosis (VCTE)
Number of patients with advanced liver disease as defined by VCTE
Measured: From December 2025 to December 2031
Prevalence of advanced fibrosis (MRE)
Number of patients with advanced liver disease as defined by MRE
Measured: From December 2025 to December 2031
Prevalence of advanced fibrosis (Clinical signs)
Number of patients with advanced liver disease as defined by clinical signs of decompensation
Measured: From December 2025 to December 2031
Progression/regression of advanced fibrosis (VCTE)
Progression/regression to/from advanced liver disease as measured with VCTE between two timepoints
Measured: From December 2025 to December 2031
Progression/regression of advanced fibrosis (MRE)
Progression/regression to/from advanced liver disease as measured with MRE between two timepoints
Measured: From December 2025 to December 2031
The association between physical activity (IFIS) and prevalent advanced fibrosis
Liver fibrosis measured according to the primary outcome definitions described above. Physical activity measured with the international fitness scale (IFIS).
Measured: From December 2025 to December 2031
The association between physical activity (Actigraph GT3X) and prevalent advanced fibrosis
Liver fibrosis measured according to the primary outcome definitions described above. Physical activity measured with Actigraph GT3X (accelerometer).
Measured: From December 2025 to December 2031
The association between physical activity (IFIS) and risk of progressing to advanced fibrosis
Liver fibrosis progression measured according to the primary outcome definitions described above. Physical activity measured with the international fitness scale (IFIS).
Measured: From December 2025 to December 2031
The association between physical activity (Actigraph GT3X) and risk of progressing to advanced fibrosis
Liver fibrosis progression measured according to the primary outcome definitions described above. Physical activity measured with Actigraph GT3X (accelerometer).
Measured: From December 2025 to December 2031
Genetic factors associated with advanced fibrosis or MASLD progression/regression
Liver fibrosis and fat measured according to the primary outcome definitions described above. Genes to be analyzed: PNPLA3, TM6SF2, MBOAT7 among others.
Measured: From December 2025 to December 2031
Association between body composition and MASLD and/or liver fibrosis and progression/regression thereof
Liver fibrosis and fat measured according to the primary outcome definitions described above. Body composition measured with AMRA Medical AB's MAsS Scan.
Measured: From December 2025 to December 2031
Secondary outcomes (5)
The association of hypertension (weekly blood pressure monitoring) and MASLD with or without signs of advanced fibrosis
Liver fibrosis and fat measured according to the primary outcome definitions described above. Hypertension measured with weekly blood pressure monitoring.
Measured: From December 2025 to December 2031
The association of hypertension (24-hour ambulatory blood pressure monitoring) and MASLD with or without signs of advanced fibrosis
Liver fibrosis and fat measured according to the primary outcome definitions described above. Hypertension measured with 24-hour ambulatory blood pressure monitoring.
Measured: From December 2025 to December 2031
The association between OSAS and MASLD with or without advanced fibrosis
Liver fibrosis and fat measured according to the primary outcome definitions described above. OSAS measured at university hospital sleep apnea clinic.
Measured: From December 2025 to December 2031
Health economic model for disease management
Markov modelling.
Measured: From January 2028 to December 2034
Number of patients that develop symptoms of end-stage liver disease
Symptoms of end-stage liver disease (e.g., ascites, encephalopathy, varices, HCC) or liver-related death will be recorded through chart review
Measured: From December 2025 to December 2034
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start16 Dec 2025
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 317 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- University Hospital, Linkoeping, Amra Medical AB
- Responsible party
- Principal investigator, Patrik Nasr, Linkoeping University
- Investigators
- Patrik Nasr, M.D., Ph.D., Principal investigator, Department of Health, Medicine and Caring Sciences, Linköping University, and Department of Gastroenterology and Hepatology, Linköping University Hospital, Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312136
- Sponsor's protocol ID
- 2024-05471-01
- Acronym
- EPSOMIP2
- Status last verified
- Oct 2026
- First submitted
- 16 Dec 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided