Prognostic Significance of Fatty Liver Disease in Bariatric Patients (PROMETHEUS)

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Morbid; Non-Alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; Metabolic Encephalopathy
• Intervention / Treatment: Procedure: Bariatric surgery

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mette M Lauridsen, MD PhD; Phone Number: +4579182000; Email: mette.enok.munk.lauridsen@rsyd.dk

Study Locations

• Denmark
  • Esbjerg, Denmark, 6700
    • Recruiting
    • Hospital of Southwest Jutland
    • Contact: Mette Lauridsen, Postdoc; Phone Number: 61661192; Email: mette.enok.munk.lauridsen@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria case group:

• Age > 18 years
• BMI >35 kg/m2 and referred for bariatric surgery at Hospital of South West Jutland, Denmark
• Able to give written informed consent.

Inclusion criteria control group:

• Age > 18 years
• BMI >35 kg/m2 with no wish to undergo bariatric surgery.
• Able to give written informed consent.

Exclusion Criteria:

• Active viral hepatitis
• Not willing or able to consent
• Contraindications to liver biopsy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention is bariatric surgery (Roux en Y gastric bypass or gastric sleeve operation).	Procedure: Bariatric surgery; Roux en y gastric bypass or gastric sleeve operation
No Intervention: Control; Age, BMI and co-morbidity matched group who do not undergo surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who will die during the follow up period in case and control group	Difference in mortality between cases and controls with various NAFLD severity on biopsy.	10 years follow up after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participant who will experience progressive fatty liver disease in case and control group	Difference NAFLD severity between case and control group after 10 years follow up. Simple steatosis is the mildest form and liver cirrhosis is the most serious manifestation: Grade 1 steatosis; Grade 2 steatosis; Grade 3 steatosis; Non alcoholic steatohepatitis; Presence of fibrosis Kleiner grade 1-2; Presence of fibrosis Kleiner grade 3; Presence of liver cirrhosis	10 years follow up after inclusion
Change in continuous reaction time measurement after bariatric surgery	Continuous reaction time measurement will measure reaction time instability and is a measure of metabolic encephalopathy. The method is a 10-minutes, computerised registration of a series of motor reaction times to an auditory stimulus, with results reported as the CRTindex (50 percentile/(90-10) percentile) as a parameter of reaction time variability. A CRT index below 1.9 i considerede abnormal a may be a sign of hepatic encephalopathy.	10 years follow up after inclusion
Change in EEG after bariatric surgery	Change in mean dominant frequency(MD) on EEG spectral analysis. EEG disturbances in hepatic encephalopathy are (rated by severity)but there is no enough space here to describe it.	24 months after surgery
Change in intelligence quotient after bariatric surgery	Measured by Weschlers adult intelligence scale (WAIS). An IQ if 100 i the norm. Range 50-150.	24 months efter surgery

Collaborators and Investigators

• Sponsor: Hospital of South West Jutland
• Collaborators: Odense University Hospital; University of Southern Denmark
• Investigators: Principal Investigator: Mette M Lauridsen, MD, PhD, Hospital of South West Jutland

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Estimated): June 1, 2035
• Study Completion (Estimated): April 1, 2038

Study Registration Dates

• First Submitted: May 1, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Brain Diseases; Obesity, Morbid; Brain Diseases, Metabolic
• Other Study ID Numbers: S-20170210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No