Back to resultsPrognostic Significance of Fatty Liver Disease in Bariatric Patients (PROMETHEUS)
Primary Purpose
Non-Alcoholic Fatty Liver Disease, Metabolic Encephalopathy, Obesity, Morbid
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Bariatric surgery
Sponsored by
About this trial
This is an interventional diagnostic trial for Non-Alcoholic Fatty Liver Disease
Eligibility Criteria
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
Sites / Locations
- Hospital of Southwest JutlandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
The intervention is bariatric surgery (Roux en Y gastric bypass or gastric sleeve operation).
Age, BMI and co-morbidity matched group who do not undergo surgery.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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.
Change in intelligence quotient after bariatric surgery
Measured by Weschlers adult intelligence scale (WAIS). An IQ if 100 i the norm. Range 50-150.
Full Information
NCT ID
NCT03535142
First Posted
May 1, 2018
Last Updated
September 21, 2023
Sponsor
Hospital of South West Jutland
Collaborators
University of Southern Denmark, Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03535142
Brief Title
Prognostic Significance of Fatty Liver Disease in Bariatric Patients
Acronym
PROMETHEUS
Official Title
Prognostic Significance of Fatty Liver Disease in Bariatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
June 1, 2035 (Anticipated)
Study Completion Date
April 1, 2038 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital of South West Jutland
Collaborators
University of Southern Denmark, Odense University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease, Metabolic Encephalopathy, Obesity, Morbid, Non-alcoholic Steatohepatitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention is bariatric surgery (Roux en Y gastric bypass or gastric sleeve operation).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Age, BMI and co-morbidity matched group who do not undergo surgery.
Intervention Type
Procedure
Intervention Name(s)
Bariatric surgery
Intervention Description
Roux en y gastric bypass or gastric sleeve operation
Primary Outcome Measure Information:
Title
Number of participants who will die during the follow up period in case and control group
Description
Difference in mortality between cases and controls with various NAFLD severity on biopsy.
Time Frame
10 years follow up after inclusion
Secondary Outcome Measure Information:
Title
Number of participant who will experience progressive fatty liver disease in case and control group
Description
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
Time Frame
10 years follow up after inclusion
Title
Change in continuous reaction time measurement after bariatric surgery
Description
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.
Time Frame
10 years follow up after inclusion
Title
Change in EEG after bariatric surgery
Description
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.
Time Frame
24 months after surgery
Title
Change in intelligence quotient after bariatric surgery
Description
Measured by Weschlers adult intelligence scale (WAIS). An IQ if 100 i the norm. Range 50-150.
Time Frame
24 months efter surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mette M Lauridsen, MD PhD
Phone
+4579182000
Email
mette.enok.munk.lauridsen@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette M Lauridsen, MD, PhD
Organizational Affiliation
Hospital of South West Jutland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of Southwest Jutland
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mette Lauridsen, Postdoc
Phone
61661192
Email
mette.enok.munk.lauridsen@rsyd.dk
12. IPD Sharing Statement
Plan to Share IPD
No
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Prognostic Significance of Fatty Liver Disease in Bariatric Patients
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