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.
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.
Age > 18 years
Active viral hepatitis
Not willing or able to consent
Contraindications to liver biopsy
Parallel
Bariatric surgery
Procedure/SurgeryRoux en y gastric bypass or gastric sleeve operation
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.
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: 1. Grade 1 steatosis 2. Grade 2 steatosis 3. Grade 3 steatosis 4. Non alcoholic steatohepatitis 5. Presence of fibrosis Kleiner grade 1-2 6. Presence of fibrosis Kleiner grade 3 7. 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.
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Esbjerg Hospital - University Hospital of Southern Denmark
Lead sponsor
University of Southern Denmark
Sponsor institution
University of Southern Denmark
Collaborator
Odense University Hospital
Collaborator
Esbjerg University Hospital of South-West Jutland
Collaborator
