Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06539494

Luminal Fructose Kinetics (MARTINI Study)

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2024-08-06

22

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Luminal Fructose Kinetics (MARTINI Study)

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years
  • Male or postmenopausal females
  • For healthy subjects: BMI less than 25
  • For MASLD/MASH patients: BMI greater than 25
  • Biopsy proven MASLD or MASH for MASLD/MASH group
  • Ability to give informed consent
Not Eligible

You will not qualify if you...

  • History of sustained excess alcohol intake: more than 30g/day for males, more than 20g/day for females
  • Diagnosis of diabetes
  • Previous bariatric surgery
  • Other liver diseases (e.g., Hepatitis B or C, Wilson disease, hemochromatosis)
  • Proton pump inhibitor use within one year before the study
  • Use of GLP1 agonists, SGLT2 inhibitors, or insulin
  • Antibiotic use in the last 3 months
  • Use of probiotics or symbiotics
  • Pregnancy
  • Chronic illnesses including heart failure, renal failure (eGFR less than 30 ml/min), pulmonary, gastrointestinal, or hematologic disorders, or other inflammatory diseases
  • Active infection
  • Use of platelet inhibitors such as ascal or clopidogrel
  • Smoking
  • Use of blood thinners
  • Heart failure

AI-Screening

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Trial Site Locations

Total: 1 location

1

Amsterdam UMC location AMC

Amsterdam, Netherlands

Actively Recruiting

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Research Team

M

Max Nieuwdorp, Prof

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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