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Prognostic Significance of Fatty Liver Disease in Bariatric Patients

Study acronym: PROMETHEUS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv7
  2. Collaborators: 2 to 3v6
  3. 3 versions Re-verified since Mar 5, 2021, no change to tracked fieldsv3-v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 1, 2018 to Aug 15, 2018
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Prospective non-randomized intervention case control study on patients with a BMI \> 35. The intervention group/cases (n=600) is comprised of bariatric patients who undergo bariatric surgery and the control group (n=600) of age, weight and comorbidity matched patients who choose not to undergo bariatric surgery. The overall aim is to examine prevalence of the spectrum of fatty liver disease (NAFLD) in these patients and the prognostic significance of NAFLD.
Trial Details
NCT Number NCT03535142
Lead Sponsor Esbjerg Hospital - University Hospital of Southern Denmark
Collaborators: University of Southern Denmark, Odense University Hospital, Esbjerg University Hospital of South-West Jutland
Conditions
(from sponsor)		 Non-Alcoholic Fatty Liver Disease, Metabolic Encephalopathy, Obesity, Morbid, Non-alcoholic Steatohepatitis
Related terms Brain Diseases, Metabolic, Non-alcoholic Fatty Liver Disease, Obesity, Morbid
Enrollment 1,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov