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Enrolling By Invitation
NCT07312136
MASLD in Type 2 Diabetes in Primary Care - a Follow-up Study
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
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 317
Sponsor: Linkoeping University
Location: Department of Gastroenterology and Hepatology, Linköping University Hospital Linköping Östergötland County
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07312136). StuddyBuddy aggregates publicly available trial information.
