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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,200
Roux en y gastric bypass or gastric sleeve operation
Hospital of Southwest Jutland
Esbjerg, Denmark
RECRUITINGNumber 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.
Time frame: 10 years follow up after inclusion
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months efter surgery
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