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Biomarkers of Steatohepatitis in Type 2 Diabetes Patients

Study acronym: STEDIB
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Eligibility criteria expanded, about 323 words
    • Secondary endpoints: details revised at 1 of 1 entry
  2. Enrollment target: 40 to 100v3 Show 6 more changesShow less
    • Primary completion date: Mar 30, 2026 to Dec 30, 2028
    • Sponsor refiled this as active, not recruiting (was completed)
    • Study sites: 1 to 2
    • Study completion date: Jun 5, 2026 to Dec 30, 2028
    • Start date: Sep 1, 2025 to Apr 18, 2024
    • Study description expanded, about 29 words
  3. Trial status: Not Yet Recruiting to Completed
    • Enrollment target: estimated 100 to confirmed 40
    • Study completion date changed from estimate of Jun 30, 2026 to Jun 5, 2026
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The aims of the study are to identify a subgroup of type 2 diabetics at risk of developing and progressing to non-alcoholic steatohepatitis (NASH), to correlate clinical and laboratory parameters with sonographic and elastographic findings in order to pinpoint indicators of liver fibrosis (NASH), and to facilitate targeted screening and intensified management of type 2 diabetes mellitus to prevent NASH complications.
Trial Details
NCT Number NCT07098520
Lead Sponsor Faculty Hospital Kralovske Vinohrady
Conditions
(from sponsor)		 Diabetes, Steatosis of Liver
Related terms Diabetes Mellitus, Fatty Liver
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov