About this trial
The goal of this clinical trial is to learn how the liver responds to sugar in people with obesity who are having bariatric surgery. Researchers want to understand differences between people with and without metabolic associated steatotic liver disease (MASLD).
The main question is:
Does giving sugar directly into the vein change how liver genes work in people with and without MASLD?
Researchers will compare:
* People with MASLD who receive sugar * People with MASLD who receive saline (salt water) * People without MASLD who receive sugar * People without MASLD who receive saline
During surgery, participants will:
* Receive either a sugar solution (35 grams of glucose in 150 mL fluid) or saline * Have small samples (biopsies) taken from the liver and fat tissue before and 45 minutes after the infusion * Provide blood samples to measure sugar, insulin, and other metabolites * Provide a one-time sample of intestinal tissue that is normally removed during surgery
This study may help explain why MASLD develops and how the liver reacts to sugar. The results could lead to new ways to understand and treat liver disease in people with obesity.
Eligibility criteria
Qualifiers
Adult individuals, age >35 < 65 years old.
BMI ≥ 40 kg/m², or a BMI ≥ 35 kg/m² with an obesity-related comorbidity
No MASLD based on Fibroscan
Estimated glomerular filtration rate (eGFR) > 60mL/min/1.73m2
Disqualifiers
Use of metformin and SGLT2/ exogenous insulin/GLP-1 RA
Primary lipid disorder
Known genetic basis for insulin resistance or glucose intolerance
All medical and psychiatric conditions except for obesity related diseases.
Trial design
Treatments tested in this trial
- [6,6-D2]-labeled glucose (intravenous)
- Saline (0.9% sodium chloride infusion)
Treatment groups
Locations
1Sponsors and collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Spaarne Gasthuis
Collaborator