Metabolic Encephalopathy, Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis, Obesity, Morbid
Conditions
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.
Interventions
PROCEDUREBariatric surgery
Roux en y gastric bypass or gastric sleeve operation
Sponsors
University of Southern Denmark
Odense University Hospital
Esbjerg University Hospital of South-West Jutland
Esbjerg Hospital - University Hospital of Southern Denmark
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who will die during the follow up period in case and control group | 10 years follow up after inclusion | Difference in mortality between cases and controls with various NAFLD severity on biopsy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participant who will experience progressive fatty liver disease in case and control group | 10 years follow up after inclusion | 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 | 10 years follow up after inclusion | 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 | 24 months after 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 | 24 months efter surgery | Measured by Weschlers adult intelligence scale (WAIS). An IQ if 100 i the norm. Range 50-150. |
Countries
Denmark
Contacts
Primary ContactMette M Lauridsen, MD PhD
Outcome results
None listed