Short summary

We examine the prevalence and prognostic significance of fatty liver disease in persons with BMI above 35 who undergo bariatric surgery and in a control group who do not. 

The novelty is that we do serial liver and fat tissue biopsies at inclusion, at surgery and after 24 months. Further, we do extensive biobanking.

The project is a collaboration between ATLAS Centre at SDU, FLASH Center at OUH and Hospital of South West Jutland. 

Rationale

Fatty liver disease is rapidly becoming the leading cause for liver disease in the Western World. This is consequence of the incresing prevalence of obesity and the metabolic syndrome. The treatment we offer for morbid obesity is bariatric surgery. The hepatic component of the metabolic syndrome is not routinely evaluated prior to surgery and consequently we lack knowledge on the prevalence and prognostic signifcance of variuos degrees of fatty liver disease i.e. steatosis, non-alcoholic steatohepatits and fibrosis. 

Description of the cohort

Inclusion criteria intervention group: 

Age > 18 yrs.

BMI >35 kg/m2 and referred for bariatric surgery at Hospital of South West Jutland

Can give informed consent.

Inclusion criteria control group: 

Age > 18 yrs

BMI >35 kg/m2 and no wish for bariatric surgery. 

Can give informed consent

Exclusion criteria:

Aktive viral hepatitis 

Contraindications to liver biopsi. 

Cancer or other comorbidity with life expectancy under 12 months.  

Data and biological material

Baseline information: 

Comorbiditet 

• diabetes
• hypothyroeidism
• hypertension
• depression
• hypercholesterolaemia
• hypertriglyceridaemia
• cardiovascular disease
• sleep apnea
• chronic kidney disease
• autoimmune diseases
• prior drug-induced liver disease (DILI)
• prior surgical procedures
• Medicine
• Etnicity
• Gender
• Smoking 
• Menopausal status
• Job status
• Educational level
• Civil status
• Biometry: 
• Bioimpedans 
• Waist circumference (cm)
• Blood pressure og pulse (mmHg)
• Weight (kg)
• Height (cm)
• BMI 
• Hand grip strength (kg)
• Standard blood tests:
• ASAT, ALAT, bilirubin, BASP, GGT
• Markers of fibrosis (FIB-4) 
• Coagulation (INR, APTT, TRC)
• Blood lipids (total cholesterol, LDL, HDL, triglycerides)
• Insulinresistence (HOMA-IR, HbA1c, C-peptid)
• Biologic material:
• Blood (plasma, full blood, serum), urine, saliva, feaces, hair, livertissue, subcutaneus fat tissue
• in most patients these samples will be drawn at time point 0, 6 months or at bariatric surgery and after 24 months. 
• Questionnaires: 
• Diet recall
• Sickness Impact Profile (SIP) 
• Yale Food Addiction Scale (YFAS) 
• Alcohol Use Disorder Test (AUDIT-C)
• Lifetime Alcohol Consumption questionnaire (LDH-q)
• Major Depression Inventory 
• Cognitive testing:
• Continous reaction time measurement (CRT) 
• Porto-systemic Encephalopathy Score (PHES) 
• Stroop Tests (EncephalApp) 
• Repeatable Battery for the Assessment of Neuropsychological Status (R-BANS) 

• Fibroscan
• MR fat quantification

Collaborating researchers and departments

Functional Genomics and Metabolomics Research Unit -ATLAS, University of Southern Denmark

• Professor Susanne Mandrup

Department of Gastrointestinal Diseases, Odense University Hospital, FLASH Centre

• Professor Aleksander Krag