Hepatic Gene Response to Intravenous Glucose in Obese Patients With and Without MASLD Undergoing … (NCT07326865) | Clinical Trial Compass
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 range
35 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)