Prognostic Significance of Fatty Liver Disease in Bariatric Patients

Study Overview
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Brief Summary
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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.

Official Title
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Prognostic Significance of Fatty Liver Disease in Bariatric Patients

Conditions
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Non-Alcoholic Fatty Liver Disease, Metabolic Encephalopathy, Obesity, Morbid, Non-alcoholic Steatohepatitis

Intervention / Treatment
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* Procedure: Bariatric surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |