Clinical Trial

Prognostic Significance of Fatty Liver Disease in Bariatric Patients

Study acronym: PROMETHEUS
Recruiting
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Summary
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2018-05-23; most recent amendment 2025-03-03.
Status change: Not Yet Recruiting → Recruiting 2019-12-10
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 Non-Alcoholic Fatty Liver Disease, Metabolic Encephalopathy, Obesity, Morbid, Non-alcoholic Steatohepatitis
Enrollment 1,200 participants
Start Date 2018-08-15
Primary Completion 2035-06-01 (estimated)
Study Completion 2038-04-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-05