Luminal Fructose Kinetics (MARTINI Study)
ConditionMASLD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About this trial
In this study the investigators aim is to explore the dynamics of (small) intestinal fructose catabolism in humans and ethanol production in relation to small intestinal signalling pathways and changes in pH, using 13C fructose isotope tracing techniques complemented with direct luminal sampling via small intestinal catheter in biopsy proven MASLD/MASH patients vs healthy (BMI\<25) subjects. Additionally the investigators will repeat the experiment after four weeks of administering omeprazole at a dose of 40 mg twice daily. Omeprazole is a proton pump inhibitor, known to elevate pH from 2-6.
Eligibility criteria
Qualifiers
Adult individuals, age > 18 <65 years
Male or postmenopauzal females
BMI <25
Ability to give informed consent In case of the MASLD/MASH group
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Omeprazole 40 MG
Treatment groups
22 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov