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MASLD in Type 2 Diabetes in Primary Care - a Follow-up Study

Study acronym: EPSOMIP2
StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints added 10 → 15 primary endpoints
See other at-risk trials from Linkoeping University

Record History

  1. Primary endpoint(s) modified Eligibility criteria expanded, about 11 words · Secondary endpoints: 4 to 5 · Study description expanded, about 299 words Show 3 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: 4 to 5
    • Study description expanded, about 299 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Linkoeping University
55 trials monitored
See 3 trials at risk
Diabetes
4,286 trials monitored
See 187 trials at risk
Obesity
3,560 trials monitored
See 142 trials at risk
Type 2 Diabetes
2,100 trials monitored
See 102 trials at risk
and 2 more diseases
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.
Trial Details
NCT Number NCT07312136
Lead Sponsor Linkoeping University
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) +1 more
Enrollment 317 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov