Evaluating the Prevalence and Severity of MASLD in Primary Care - a Follow-up Study
| Registry | NCT07312136, acronym EPSOMIP2 |
|---|---|
| Status | Enrolling by invitation |
| Study type | Observational |
| Enrollment | 317 (Estimated) |
| Sponsor | Linkoeping University (Other gov); collaborators: University Hospital, Linkoeping, Amra Medical AB |
| Conditions | MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Cirrhosis, Advanced Fibrosis, Sarcopenia, Obesity & Overweight, Type 2 Diabetes, Hypertension, OSAS (Obstructive Sleep Apneas Syndrome), Metabolic Syndrome |
| Dates | start 2025-12-16, primary completion 2031-12-31 (estimated), completion 2034-12-31 (estimated), first posted 2025-12-31, last updated 2026-10-09 |
| Locations | 1 site in Sweden |
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All trials for MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease All trials for Cirrhosis
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. How common are MASLD and advanced liver fibrosis at long-term follow-up?
2. 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.
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.
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Previously included and completed the assessments in the EPSONIP study (NCT03864510) * Age >/= 18 years * Informed consent Exclusion Criteria: * Contraindication to magnetic resonance imaging * Other primary liver disease than MASLD diagnosed after inclusion in the EPSONIP study (NCT03864510) * Liver transplantation
| Facility | City | Country | Status |
|---|---|---|---|
| Department of Gastroenterology and Hepatology, Linköping University Hospital | Linköping, Östergötland County | Sweden |