Status:
RECRUITING
Luminal Fructose Kinetics (MARTINI Study)
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
MASLD
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 change...
Detailed Description
The investigators will perform a non blinded single centre intervention study in 2x 11 participants Participants will be either healthy volunteers with a BMI \< 25 and Age 18-65 or patients with MASL...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06539494
Start Date
July 1 2024
End Date
April 1 2026
Last Update
August 6 2024
Active Locations (1)
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1
Amsterdam UMC location AMC
Amsterdam, Netherlands