Actively Recruiting
Hepatic Gene Response to Intravenous Glucose in Obese Patients With and Without MASLD Undergoing Bariatric Surgery
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2026-01-08
40
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
S
Spaarne Gasthuis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hepatic Gene Response to Intravenous Glucose in Obese Patients With and Without MASLD Undergoing Bariatric Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged over 35 and under 65 years
- Stable weight with no more than 3% total weight loss from screening to surgery
- Able to give informed consent
- Agree to have tissue biopsies taken during surgery, including 2 liver, subcutaneous, visceral, omental, and a one-time jejunal biopsy
- For obese non-MASLD patients: BMI of 40 kg/m2 or higher, or BMI of 35 kg/m2 or higher with obesity-related health conditions
- No MASLD diagnosis based on Fibroscan
- Estimated glomerular filtration rate (eGFR) greater than 60 mL/min/1.73m2
- For obese MASLD patients: diagnosis of MASLD by Fibroscan
- Compensated liver disease meeting blood count and chemistry criteria: ALAT less than 10 times upper limit of normal, hemoglobin above 11 g/dL (females) or 12 g/dL (males), white blood cells above 2.5 K/µL, neutrophils above 1.5 K/µL, platelets above 100 K/µL, total bilirubin less than 35 µmol/L, albumin above 30 g/L, total protein above 80% or INR below 1.4
- Serum creatinine below 1.3 mg/dL (men) or 1.1 mg/dL (women) or eGFR above 60 mL/min/1.73m2
You will not qualify if you...
- Use of metformin, SGLT2 inhibitors, exogenous insulin, or GLP-1 receptor agonists
- Primary lipid disorders
- Known genetic causes of insulin resistance or glucose intolerance
- Any medical or psychiatric condition other than obesity-related diseases
- Uncontrolled high blood pressure (above 150/95 mmHg)
- Chronic kidney disease with creatinine above 150 umol/L
- Pregnancy or breastfeeding
- Any other form of liver disease besides MASLD
- History of sustained excess alcohol use: more than 30 g/day for men, more than 20 g/day for women
- Significant systemic or major illnesses including severe heart failure, unstable coronary artery disease, stroke, lung disease, kidney failure, organ transplant, serious psychiatric disease, active cancer, or immune system problems
- Body mass index (BMI) over 45 kg/m2
- Type 1 or type 2 diabetes
- Blood clotting disorders or current use of blood thinners
- Known heart failure
- Contraindications for liver biopsy
- History or current heart rhythm problems or cardiovascular events except controlled hypertension
AI-Screening
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Trial Site Locations
Total: 1 location
1
AMC
Amsterdam, North Holland, Netherlands, 1105AZ
Actively Recruiting
Research Team
D
Daniël P Baars, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
FACTORIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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