RecruitingNot Applicable

Hepatic Gene Response to Intravenous Glucose in Obese Patients With and Without MASLD Undergoing Bariatric Surgery

Netherlands40 participantsStarted 2025-11-12

Plain-language summary

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.

Who can participate

Age range35 Years – 65 Years

SexALL

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Inclusion Criteria: To be eligible to participate in this study, a subject must meet all of the following criteria: Adult individuals, age \>35 \< 65 years old. Stable weight (no more than 3% TWL of initial body weight from screening to surgery) Subjects should be able to give informed consent Subjects agree to have tissue biopsies performed during surgery, that is 2 liver, subcutaneous, visceral and omental biopsies plus a one-time jejunal biopsy. For obese non-MASLD patients: * 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 For obese MASLD patients: * MASLD diagnosis according to Fibroscan * Compensated liver disease with the following hematologic and biochemical criteria on entry into study: * ALAT \<10x ULN * Hemoglobin \> 11g/dL for females and 12 g/dL for males * White blood cell (WBC) \> 2.5 K/ μL * Neutrophil count \> 1.5 K μL * Platelets \> 100 K/μL * Total bilirubin \<35 μmol/L * Albumin \>30 g/L * TP \>80% or INR \<1.4 * Serum creatinine \<1.3 mg/dL (men) or \<1.1 mg/dL (women) or * Estimated glomerular filtration rate (eGFR) \> 60mL/min/1.73m2 Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Use of metformin and SGLT2/ exogenous insulin/GLP-1 RA * Primary lipid disorder * Known genetic basi…

What they're measuring

Change from baseline in hepatic gene expression at 45 minutes after intravenous glucose bolus compared to saline infusion

Timeframe: Baseline (pre-infusion, at start of surgery) to 45 minutes after infusion during bariatric surgery

Trial details

NCT IDNCT07326865

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05

Contact for this trial

Daniël P Baars, MD

0650063930 d.p.baars@amsterdamumc.nl