fatty liver disease Non-alcoholic fatty liver disease
Conditions
Interventions
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Diagnosis of NASH on liver biopsy taken on clinical grounds at the outpatient clinic - 18-65 years of age - BMI > 25 kg/m2 - Subjects should be able to give informed consent, Healthy controls: - BMI >25 kg/m2 - 18-65 years of age - Subjects should be able to give informed consent
Exclusion criteria
Exclusion criteria: - Primary lipid disorder - Known genetic basis for insulin resistance or glucose intolerance - Ethanol intake - Pregnancy, females who are breastfeeding - Hepatitis B and/or C - Auto-immune hepatitis - Wilson disease/ alpha 1-antitripsine deficiency - Hemochromatosis - Use of drugs interacting with Fomepizole (products requiring CYP2E1 for metabolizing). - Use of drugs interacting with Clindamycine, metronidazole or ciprofloxacin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peripheral ethanol plasma concentrations in subjects undergoing a mixed meal tolerance test after receiving an infusion with and without fomepizole (15mg/kg in 30-45 min intravenously) . 1. Assessment of hepatic steatosis with ultrasonography of the liver prior to the mixed meal tolerance test. 2. 5h Mixed meal tolerance test for concentrations of plasma ethanol and insulin sensitivity (HOMA) 3. 5h Mixed meal tolerance test for concentrations of plasma ethanol after antibiotic treatment 4. Oral and faecal microbiota composition 5. Dietary and satiety lists 6. Clinical data (body weight, waist circumference, in addition information will be collected regarding medication, comorbidity, smoking,) 7. Causality of endogenous plasma ethanol production by intestinal microbiota as shown by reducted peripheral levels upon fomipizol infusion due to short term oral antibiotics course | — |
Secondary
| Measure | Time frame |
|---|---|
| - | — |
Countries
The Netherlands
Outcome results
None listed