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Life sciences · Observational Study
ClinicalTrials.gov · October 9, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07312136). This is a study registration, not published results. Lead sponsor: Linkoeping University. Recruitment status: ENROLLING_BY_INVITATION. Study type: OBSERVATIONAL. Enrollment: 317 participants (ESTIMATED). 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. Primary outcome measures: Prevalence of MASLD (MRI-PDFF) , From December 2025 to December 2031; Prevalence of MASLD (CAP) , From December 2025 to December 2031; Progression/regression of MASLD (MRI-PDFF) , From December 2025 to December 2031; Progression/regression of MASLD (CAP) , From December 2025 to December 2031; Prevalence of advanced fibrosis (VCTE) , From December 2025 to December 2031; Prevalence of advanced fibrosis (MRE) , From December 2025 to December 2031; Prevalence of advanced fibrosis (Clinical signs) , From December 2025 to December 2031; Progression/regression of advanced fibrosis (VCTE) , From December 2025 to December 2031; Progression/regression of advanced fibrosis (MRE) , From December 2025 to December 2031; The association between physical activity (IFIS) and prevalent advanced fibrosis , From December 2025 to December 2031; The association between physical activity (Actigraph GT3X) and prevalent advanced fibrosis , From December 2025 to December 2031; The association between physical activity (IFIS) and risk of progressing to advanced fibrosis , From December 2025 to December 2031; The association between physical activity (Actigraph GT3X) and risk of progressing to advanced fibrosis , From December 2025 to December 2031; Genetic factors associated with advanced fibrosis or MASLD progression/regression , From December 2025 to December 2031; Association between body composition and MASLD and/or liver fibrosis and progression/regression thereof , From December 2025 to December 2031. Brief 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. 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.