RecruitingPhase 2NCT06539494

Luminal Fructose Kinetics (MARTINI Study)

Luminal Fructose Kinetics (MARTINI) (2024)


Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

22 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria10

  • In case of the healthy subject group:
  • Adult individuals, age > 18 <65 years
  • Male or postmenopauzal females
  • BMI <25
  • Ability to give informed consent In case of the MASLD/MASH group
  • Adult individuals, age > 18 <65 years
  • Male or postmenopauzal females
  • BMI > 25
  • Biopsy proven MASLD/MASH
  • Ability to give informed consent

Exclusion Criteria15

  • 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 <30 ml/min), pulmonary disease, gastrointestinal disorders, or hematologic diseases), or other inflammatory diseases
  • Active infection
  • Use of ascal, clopidogrel or other platelet inhibition
  • Smoking
  • Blood thinners
  • Heart failure

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGOmeprazole 40 MG

Proton pump inhibitor twice a day for 4 weeks


Locations(1)

Amsterdam UMC location AMC

Amsterdam, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06539494


Related Trials