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New treatment option for MASLD
Official title Hepatic Gene Response to Intravenous Glucose in Obese Patients With and Without MASLD Undergoing Bariatric Surgery
ClinicalTrials.gov ID: NCT07326865
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 65
You may be able to join if
- 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...
- 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:
You likely can't join if
- 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)
See the full eligibility 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...
- 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
- 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)
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, North Holland, Netherlands
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 35 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, North Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.