NCT07312136|Enrolling By InvitationDMC
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
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EPSOMIP2
Evaluating the Prevalence and Severity of MASLD in Primary Care - a Follow-up Study
Sponsor study identifier
observational
317
1 country
1
Study Start
December 16, 2025
Actual (reported)Primary Completion
December 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2034
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2034
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 16, 2025
Actual (reported)December 16, 2025
Actual (reported)December 31, 2025
Actual (reported)December 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2034
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Prevalence of MASLD (MRI-PDFF)
Number of patients with MASLD measured with MRI-PDFF
From December 2025 to December 2031
Prevalence of MASLD (CAP)
Number of patients with MASLD measured with CAP
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
From December 2025 to December 2031
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.
Department of Gastroenterology and Hepatology, Linköping University Hospital
Linköping, Östergötland County, 58185, Sweden
Serum, Plasma, DNA, RNA, urine
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
First Submitted
December 16, 2025
First Posted
December 31, 2025
Study Start
December 16, 2025
Actual (reported)Primary Completion
December 31, 2031
EstimatedEffect of Sinbiotic With Multispecies Probiotics on Liver Parameters Liver Enzymes, Ultrasound, Elastography and Adipokines in Same Cases) in Patients With Metabolic Associated Steatotic Liver Disease.
Assessment of Non-Invasive Testing in Major Liver-Related Outcomes
Progression/regression of MASLD (CAP)
Number of patients who progress/regress to/from MASLD between two timepoints as measured with CAP
From December 2025 to December 2031
Prevalence of advanced fibrosis (VCTE)
Number of patients with advanced liver disease as defined by VCTE
From December 2025 to December 2031
Prevalence of advanced fibrosis (MRE)
Number of patients with advanced liver disease as defined by MRE
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
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
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
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).
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).
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).
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).
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.
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.
From December 2025 to December 2031
The association of hypertension (weekly blood pressure monitoring) and MASLD with or without signs of advanced fibrosis
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
From December 2025 to December 2031
The association between OSAS and MASLD with or without advanced fibrosis
From December 2025 to December 2031
Health economic model for disease management
From January 2028 to December 2034
Number of patients that develop symptoms of end-stage liver disease
From December 2025 to December 2034
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2034
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 9, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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