fatty liver Non-alcoholic fatty liver disease
Conditions
Interventions
None listed
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Able to understand and sign the informed consent Able to speak Dutch Between 18-80 years BMI >25 kg/m² Having one of the following conditions: 1)overweight, 2) obesity, 3) type 2 diabetes mellitus, 4) cardiovascular diseases (hypertension, atherosclerosis, angina pectoris, ischaemic heart condition, cerebrovascular condition) Additional inclusion criteria valid only for the other food additives and limonene breath test • All those listed in the main protocol + • NAFLD F2-F3-F4 fibrosis stage (FibroScan >= 7.5 kPa) • Capability to complete an overnight fasting (>=10h) • Willingness to share data with Owlstone Medical LTD.
Exclusion criteria
Exclusion criteria: Excessive alcohol use o more than 20 g/day for women and 30g/day for men o >2 glasses alcohol/day for women and >3 glasses for men Other liver diseases: Hepatitis B virus, Hepatitis C virus, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson*s disease, Alpha 1 antitrypsin deficiency Secondary causes for steatosis: disorders of lipid metabolism, HCV Genotype 3, total parental nutrition, severe surgical weight loss, medications (amiodarone, tamoxifen, methotrexate, corticosteroids and HAART), lean steatosis, Celiac disease, environmental toxicity Pregnancy and breastfeeding. A history of bariatric surgery. Diagnosis of liver cirrhosis and/or hepatocellular carcinoma. Current diagnosis of extrahepatic malignancy(s) or prior diagnosis within last 5 years. Individuals about to undergo a surgery or otherwise medical procedure that will interfere with data collection and analyses planned within the current cohort, will initially be excluded from participation, but are offered the opportunity to participate at a later moment in time (e.g., after 3 months are myocardial infarction patients are eligible for participation). Additional inclusion criteria valid only for the other food additives and limonene breath test • All those listed in the main protocol + • Inability to complete the breath sampling procedure • Known carrier of a-1 Antitrypsin deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this cohort is the diagnosis of NAFLD with fibrosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| • The degree of hepatic steatosis and/or fibrosis (using FibroScan® and non-invasive score calculation) • The presence of hepatic inflammation (e.g. using biochemical parameters) • Association between lifestyle, metabolic and inflammatory parameters by collecting filled in questionnaires, anthropometric data, blood, urine, and exhaled air. • Receiver operating characteristic curves (ROC), sensitivity, specificity, and accuracy of a limonene breath levels before and after food additives administration, obtained by comparing breath benzylalcohol, 2-pentanol, 2-butanol, nonanal and limonene levels of patients with progressed NALFD (FibroScan >=7.5 kPa) to patients with earlier NAFLD (FibroScan = |0.7| will be considered as threshold for the presence of a correlation between breath benzylalcohol, 2-pentanol, 2-butanol, nonanal and limonene levels and: 1) FibroScan kPa, expected positive 2) Body parameters (i.e., height, weight, BMI), no correlation 3) Biomarkers of liver function (i.e., Bilirubin, albumin, PT-INR), Negative for albumin, positive for the others(57) 4) Biomarker of liver damage (ALT, ALP, AST), no correlation(57) 5) Fib-4, positive correlation 6) MELD and UKELD, positive correlation 7) Comorbidities and complications (i.e., diabetes, portal hypertension) | — |
Countries
Netherlands
Contacts
Public ContactGH Koek
Universiteit Maastricht
Outcome results
None listed