Hepatic steatosis metabolic dysfunction associated liver disease
Conditions
Interventions
Omeprazole orally given twice a day 40mg for four weeks
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: In case of the healthy subject group: - Adult individuals, age > 18 <65 years - male / postmenopausal female - BMI <25 - Ability to give informed consent In case of the MASLD/MASH group - Adult individuals, age > 18 <65 years - BMI > 25 - male / postmenopausal female - MASLD/MASH , either biopsy prover or defined by liver Elastography (fibrsocan) CAP values > 278 dB/m in combination with obesity - Ability to give informed consent
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - History of sustained excess alcohol ingestion: daily consumption >30g/day (3 drinks per day) for males and >20 g/day (2 drinks per day) for females - Patients with diabetes - Bariatric surgery - Other forms of liver disease (e.g. Hepatitis B,C, Wilson disease, hemochromatosis) - Proton-pump inhibitor usage one year prior to study participation - GLP1, SGLT2i or insulin use - Antibiotic use for the past 3 months - Probiotic or symbiotic usage - Pregnant women - Chronic illness (including a known history of heart failure, renal failure (eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in host/microbial intestinal (postprandial) fructose kinetics (by 13C incorporation in glucose and ethanol as well as other metabolites) in small intestinal fluid as well as plasma, urine and breath samples (whole body metabolism) and establish the role of (small) intestinal luminal pH (which is increased upon proton pump inhibitor for 4 weeks of oral omeprazole 2dd 40mg) in biopsy proven MASLD/MASH subjects versus healthy (BMI | — |
Secondary
| Measure | Time frame |
|---|---|
| - Differences in expression of small intestinal biopsy RNAseq based genes (including host alcohol dehydrogenase genes) before and after omeprazole - Changes in oral, small intestinal as well as in fecal microbiota including bacterial alcohol dehydrogenase genes and intestinal pH + alcohol dehydrogenase in feces (since elevated ADH in feces is a measure for increased ethanol exposure) - Changes in Dietary intake between two vistis (by online Eetmeter at week 0 and week 3) - To model differences in 13C- fructose whole body handling between the healthy and MASLD/MASH patients by tracking the label in metabolites (mainly glucose) in peripheral circulation, breathe, and feces and urine for excretion. | — |
Countries
Netherlands
Contacts
Public ContactM. Koning
Amsterdam UMC
Outcome results
None listed