MASLDGHASTNCT07326865
Hepatic Gene Response to Intravenous Glucose in Obese Patients With and Without MASLD Undergoing Bariatric Surgery
A study testing [6,6-D2]-labeled glucose (intravenous) and Saline (0.9% sodium chloride infusion) in people with MASLD, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- MASLD
- What is being tested?
- [6,6-D2]-labeled glucose (intravenous) and Saline (0.9% sodium chloride infusion)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Nov 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- 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 basis for insulin resistance or glucose intolerance
- All medical and psychiatric conditions except for obesity related diseases.
- Uncontrolled hypertension (RR > 150/95 mmHg)
Show all 16Show fewer
- Chronic kidney disease (creatinine > 150 umol/L)
- Pregnancy, females who are breastfeeding
- Evidence of another form of liver disease
- 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
- Significant systemic or major illnesses other than liver disease, including congestive heart failure (class C and D of the AHA), unstable coronary artery disease, cerebrovascular disease, pulmonary disease, kidney failure, organ transplantation, serious psychiatric disease, active malignancy, compromised immunity
- Body mass index (BMI) >45 kg/m2
- Type 1 or type 2 diabetes
- Hemostasis disorders or current treatment with anticoagulants
- Known heart failure
- Contra-indication for liver biopsy History of/or current cardiac dysrhythmias and/or a history of cardiovascular events including myocardial infarction, except patients with only well-controlled hypertension
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
AMC
Amsterdam, North Holland, 1105AZ
Daniël P Baars, 0650063930, d.p.baars@amsterdamumc.nl
About this study
Official title: Glucose IV and Its Hepatic Outcomes After a Metabolic Stress Test During Bariatric Surgery in Obese Patients With and Without MASLD
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:
Read more
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.
Read the detailed description
Metabolic Associated Steatotic Liver Disease (MASLD) is the most common chronic liver disease worldwide and a major cause of liver-related illness and death. Current knowledge is largely based on fasting-state liver biopsies, which do not capture the transcriptional changes triggered by nutrient intake. Postprandial dysfunction is a hallmark of MASLD, yet the molecular mechanisms in human liver tissue under metabolic stress remain poorly understood.
This study uses bariatric surgery as a unique opportunity to obtain paired liver and adipose tissue biopsies before and after an intravenous glucose challenge. By administering a 35-gram bolus of [6,6-D2]-labeled glucose during surgery, researchers can mimic the caloric load of a high-sugar meal while controlling for confounding factors such as anesthesia and surgical stress through saline control groups.
The design is a single-center, interventional, 2 × 2 factorial trial with 40 obese participants (20 with MASLD, 20 without MASLD). Participants are randomized to receive either labeled glucose or saline. Biopsies of liver, subcutaneous, omental, and visceral adipose tissue are collected at baseline and 45 minutes after infusion. Jejunal tissue routinely removed during Roux-en-Y gastric bypass is also analyzed for transcriptomic and microbiome profiling.
Primary analyses focus on single-cell RNA sequencing of liver biopsies to identify transcriptional changes induced by glucose infusion and to compare responses between MASLD and non-MASLD participants. Secondary analyses include transcriptomic profiling of adipose depots (subcutaneous, visceral and omental), jejunal tissue, and untargeted metabolomics/proteomics of plasma samples. The use of stable isotope-labeled glucose allows tracing of metabolic pathways, including erythritol synthesis via the pentose phosphate pathway.
This approach builds on prior work done using the BARIA cohort (DOI: 10.1111/joim.13157), which demonstrated that postprandial states reveal clinically relevant differences in metabolic health not apparent in fasting conditions. By integrating tissue transcriptomics, plasma metabolomics, and microbiome data, the GHAST study aims to uncover mechanisms of metabolic dysregulation in MASLD and identify novel therapeutic targets.
- Conditions
- MASLD
- Being tested
- [6,6-D2]-labeled glucose (intravenous), Saline (0.9% sodium chloride infusion)
- Keywords
- MASLD (Metabolic Associated Steatotic Liver Disease), Obesity, Bariatric surgery, Roux-en-Y gastric bypass (RYGB), [6,6-D2]-labeled glucose, Hepatic gene expression, RNA sequencing, Adipose tissue transcriptomics, Metabolomics, Postprandial metabolism
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[6,6-D2]-labeled glucose (intravenous)Other
Participants receive a 35-gram intravenous bolus of [6,6-D2]-labeled glucose dissolved in 150 mL solution. The infusion is administered at the start of bariatric surgery over 3-5 minutes via an indwelling catheter. Liver and adipose tissue biopsies are collected before infusion and 45 minutes after infusion to assess transcriptomic changes. Blood samples are taken at multiple timepoints to measure glucose, insulin, and plasma metabolites, metabolites can be traced using the labeled glucose.
Saline (0.9% sodium chloride infusion)Other
Also called Intravenous saline
Participants receive an intravenous infusion of 150 mL saline (0.9% sodium chloride) at the start of bariatric surgery. The infusion is administered over 3-5 minutes via an indwelling catheter. Liver and adipose tissue biopsies are collected before infusion and 45 minutes after infusion to serve as controls for transcriptomic and metabolic changes.
| Study group | Role | What they receive |
|---|---|---|
| MASLD + Glucose | Experimental | Participants with metabolic associated steatotic liver disease (MASLD) undergoing bariatric surgery receive a 35-gram intravenous bolus of [6,6-D2]-labeled glucose in 150 mL solution. Receives: Other: [6,6-D2]-labeled glucose (intravenous) |
| MASLD + Saline | Placebo comparator | Participants with MASLD undergoing bariatric surgery receive an intravenous infusion of 150 mL saline (0.9% sodium chloride) Receives: Other: Saline (0.9% sodium chloride infusion) |
| Non-MASLD + Glucose | Experimental | Participants without MASLD undergoing bariatric surgery receive a 35-gram intravenous bolus of [6,6-D2]-labeled glucose in 150 mL solution. Receives: Other: [6,6-D2]-labeled glucose (intravenous) |
| Non-MASLD + Saline | Placebo comparator | Participants without MASLD undergoing bariatric surgery receive an intravenous infusion of 150 mL saline (0.9% sodium chloride). Receives: Other: Saline (0.9% sodium chloride infusion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in hepatic gene expression at 45 minutes after intravenous glucose bolus compared to saline infusion
Liver biopsies are collected at two timepoints: (1) baseline, immediately after anesthesia induction and before infusion, and (2) 45 minutes after infusion of either [6,6-D2]-labeled glucose or saline. Single-cell RNA sequencing (scRNA-seq) is performed on these paired samples to measure changes in hepatic gene expression. The primary comparison is the difference in transcriptomic profiles between baseline and 45 minutes post-infusion, stratified by MASLD status (confirmed by Fibroscan and histology). Gene expression changes are quantified as fold-change in transcript abundance, normalized to baseline values.
Measured: Baseline (pre-infusion, at start of surgery) to 45 minutes after infusion during bariatric surgery
Secondary outcomes (6)
Change in gene expression in subcutaneous, omental, and visceral adipose tissue
Biopsies of subcutaneous, omental, and visceral adipose tissue are collected at two timepoints: (1) baseline, immediately after anesthesia induction and before infusion, and (2) 45 minutes after infusion of either [6,6-D2]-labeled glucose or saline. Single-cell RNA sequencing is performed to assess transcriptomic changes in each adipose depot. Gene expression changes are reported as fold-change relative to baseline values, stratified by MASLD status and intervention group.
Measured: Baseline (pre-infusion) to 45 minutes post-infusion during bariatric surgery
Jejunal tissue gene expression profile
Jejunal tissue routinely removed during Roux-en-Y gastric bypass surgery will be collected once during surgery. Transcriptomic profiling (bulk RNA sequencing) will be performed to characterize jejunal gene expression.
Measured: One-time collection during bariatric surgery
Plasma metabolite changes following labeled glucose infusion
Plasma samples collected at baseline and post-infusion will be analyzed using metabolomics to quantify changes in metabolites related to glucose catabolism, including isotope-labeled metabolites.
Measured: Baseline (pre-infusion) to 45 minutes post-infusion during bariatric surgery
Insulin sensitivity index derived from IVGTT
Plasma glucose and insulin concentrations measured during the IVGTT will be used to calculate a prespecified insulin sensitivity index (reported as a single derived value per participant per timepoint).
Measured: Baseline (pre-infusion) to 45 minutes post-infusion during bariatric surgery
Intra-jejunal microbiota composition
Intra-jejunal contents collected once during bariatric surgery will be analyzed to characterize microbiota composition.
Measured: One-time collection during bariatric surgery.
Plasma protein changes following labeled glucose infusion
Plasma samples collected at baseline and post-infusion will be analyzed using proteomic profiling to quantify changes in circulating proteins related to metabolic pathways.
Measured: Baseline (pre-infusion) to 45 minutes post-infusion during bariatric surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start12 Nov 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLDStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Spaarne Gasthuis
- Responsible party
- Principal investigator, Max Nieuwdorp, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Max Nieuwdorp, Prof. Dr., Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326865
- Sponsor's protocol ID
- 2025.0097
- Acronym
- GHAST
- Status last verified
- Jun 2025
- First submitted
- 3 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose IV and Its Hepatic Outcomes After a Metabolic Stress Test During Bariatric Surgery in Obese Patients With and Without MASLD
- ClinicalTrials.gov ID
- NCT07326865
- Acronym / sponsor ID
- GHAST / 2025.0097
- Conditions
- MASLD
- Keywords
- MASLD (Metabolic Associated Steatotic Liver Disease), Obesity, Bariatric surgery, Roux-en-Y gastric bypass (RYGB), [6,6-D2]-labeled glucose, Hepatic gene expression, RNA sequencing, Adipose tissue transcriptomics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Spaarne Gasthuis
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Metabolic Associated Steatotic Liver Disease (MASLD) is the most common chronic liver disease worldwide and a major cause of liver-related illness and death. Current knowledge is largely based on fasting-state liver biopsies, which do not capture the transcriptional changes triggered by nutrient intake. Postprandial dysfunction is a hallmark of MASLD, yet the molecular mechanisms in human liver tissue under metabolic stress remain poorly understood.
This study uses bariatric surgery as a unique opportunity to obtain paired liver and adipose tissue biopsies before and after an intravenous glucose challenge. By administering a 35-gram bolus of [6,6-D2]-labeled glucose during surgery, researchers can mimic the caloric load of a high-sugar meal while controlling for confounding factors such as anesthesia and surgical stress through saline control groups.
The design is a single-center, interventional, 2 × 2 factorial trial with 40 obese participants (20 with MASLD, 20 without MASLD). Participants are randomized to receive either labeled glucose or saline. Biopsies of liver, subcutaneous, omental, and visceral adipose tissue are collected at baseline and 45 minutes after infusion. Jejunal tissue routinely removed during Roux-en-Y gastric bypass is also analyzed for transcriptomic and microbiome profiling.
Primary analyses focus on single-cell RNA sequencing of liver biopsies to identify transcriptional changes induced by glucose infusion and to compare responses between MASLD and non-MASLD participants. Secondary analyses include transcriptomic profiling of adipose depots (subcutaneous, visceral and omental), jejunal tissue, and untargeted metabolomics/proteomics of plasma samples. The use of stable isotope-labeled glucose allows tracing of metabolic pathways, including erythritol synthesis via the pentose phosphate pathway.
This approach builds on prior work done using the BARIA cohort (DOI: 10.1111/joim.13157), which demonstrated that postprandial states reveal clinically relevant differences in metabolic health not apparent in fasting conditions. By integrating tissue transcriptomics, plasma metabolomics, and microbiome data, the GHAST study aims to uncover mechanisms of metabolic dysregulation in MASLD and identify novel therapeutic targets.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MASLD + Glucose | Experimental | Other: [6,6-D2]-labeled glucose (intravenous)Participants with metabolic associated steatotic liver disease (MASLD) undergoing bariatric surgery receive a 35-gram intravenous bolus of [6,6-D2]-labeled glucose in 150 mL solution. |
| MASLD + Saline | Placebo comparator | Other: Saline (0.9% sodium chloride infusion)Participants with MASLD undergoing bariatric surgery receive an intravenous infusion of 150 mL saline (0.9% sodium chloride) |
| Non-MASLD + Glucose | Experimental | Other: [6,6-D2]-labeled glucose (intravenous)Participants without MASLD undergoing bariatric surgery receive a 35-gram intravenous bolus of [6,6-D2]-labeled glucose in 150 mL solution. |
| Non-MASLD + Saline | Placebo comparator | Other: Saline (0.9% sodium chloride infusion)Participants without MASLD undergoing bariatric surgery receive an intravenous infusion of 150 mL saline (0.9% sodium chloride). |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
- 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
Key exclusion criteria (16 listed)
- 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 basis for insulin resistance or glucose intolerance
- All medical and psychiatric conditions except for obesity related diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [6,6-D2]-labeled glucose (intravenous)Participants receive a 35-gram intravenous bolus of [6,6-D2]-labeled glucose dissolved in 150 mL solution. The infusion is administered at the start of bariatric surgery over 3-5 minutes via an indwelling catheter. Liver and adipose tissue biopsies are collected before infusion and 45 minutes after infusion to assess transcriptomic changes. Blood samples are taken at multiple timepoints to measure glucose, insulin, and plasma metabolites, metabolites can be traced using the labeled glucose. | Other | MASLD + Glucose, Non-MASLD + Glucose |
| Saline (0.9% sodium chloride infusion)Also: Intravenous salineParticipants receive an intravenous infusion of 150 mL saline (0.9% sodium chloride) at the start of bariatric surgery. The infusion is administered over 3-5 minutes via an indwelling catheter. Liver and adipose tissue biopsies are collected before infusion and 45 minutes after infusion to serve as controls for transcriptomic and metabolic changes. | Other | MASLD + Saline, Non-MASLD + Saline |
Primary outcome
Change from baseline in hepatic gene expression at 45 minutes after intravenous glucose bolus compared to saline infusion
Time frame: Baseline (pre-infusion, at start of surgery) to 45 minutes after infusion during bariatric surgery
Liver biopsies are collected at two timepoints: (1) baseline, immediately after anesthesia induction and before infusion, and (2) 45 minutes after infusion of either [6,6-D2]-labeled glucose or saline. Single-cell RNA sequencing (scRNA-seq) is performed on these paired samples to measure changes in hepatic gene expression. The primary comparison is the difference in transcriptomic profiles between baseline and 45 minutes post-infusion, stratified by MASLD status (confirmed by Fibroscan and histology). Gene expression changes are quantified as fold-change in transcript abundance, normalized to baseline values.
6 secondary outcomes
Change in gene expression in subcutaneous, omental, and visceral adipose tissue
Time frame: Baseline (pre-infusion) to 45 minutes post-infusion during bariatric surgery
Jejunal tissue gene expression profile
Time frame: One-time collection during bariatric surgery
Plasma metabolite changes following labeled glucose infusion
Time frame: Baseline (pre-infusion) to 45 minutes post-infusion during bariatric surgery
Insulin sensitivity index derived from IVGTT
Time frame: Baseline (pre-infusion) to 45 minutes post-infusion during bariatric surgery
Intra-jejunal microbiota composition
Time frame: One-time collection during bariatric surgery.
Plasma protein changes following labeled glucose infusion
Time frame: Baseline (pre-infusion) to 45 minutes post-infusion during bariatric surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Undecided
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MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Max Nieuwdorp, Prof. Dr. principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [6,6-D2]-labeled glucose (intravenous) and Saline (0.9% sodium chloride infusion) in people with MASLD, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniël P Baars, MD (0650063930, d.p.baars@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in hepatic gene expression at 45 minutes after intravenous glucose bolus compared to saline infusion (time frame: Baseline (pre-infusion, at start of surgery) to 45 minutes after infusion during bariatric surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.