[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618072":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":40,"centralContacts":45,"locations":51,"responsibleParty":69,"collaborators":72,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":33,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":54,"whyStopped":33,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Other: [6,6-D2]-labeled glucose (intravenous)",{"label":15,"type":16,"description":17,"interventionNames":18},"MASLD + Saline","PLACEBO_COMPARATOR","Participants with MASLD undergoing bariatric surgery receive an intravenous infusion of 150 mL saline (0.9% sodium chloride)",[19],"Other: Saline (0.9% sodium chloride infusion)",{"label":21,"type":10,"description":22,"interventionNames":23},"Non-MASLD + Glucose","Participants without MASLD undergoing bariatric surgery receive a 35-gram intravenous bolus of \\[6,6-D2\\]-labeled glucose in 150 mL solution.",[13],{"label":25,"type":16,"description":26,"interventionNames":27},"Non-MASLD + Saline","Participants without MASLD undergoing bariatric surgery receive an intravenous infusion of 150 mL saline (0.9% sodium chloride).",[19],[29,34],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"[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.",[9,21],null,{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Saline (0.9% sodium chloride infusion)","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.",[15,25],[39],"Intravenous saline",[41],{"name":42,"affiliation":43,"role":44},"Max Nieuwdorp, Prof. Dr.","Amsterdam UMC","PRINCIPAL_INVESTIGATOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":33,"email":50},"Daniël P Baars, MD","CONTACT","0650063930","d.p.baars@amsterdamumc.nl",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"AMC","RECRUITING","Amsterdam","North Holland","1105AZ","Netherlands","NL",{"type":61,"coordinates":62},"Point",[63,64],4.88969,52.37403,{"lat":64,"lon":63},[67],{"name":68,"role":48,"phone":49,"phoneExt":33,"email":50},"Daniël P Baars",{"type":44,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Max Nieuwdorp","Prof. Dr.",[73],{"name":74,"class":6},"Spaarne Gasthuis","100618072","hepatic-gene-response-to-intravenous-glucose-in-obese-patients-with-and-without-masld-undergoing-bariatric-surgery-100618072",false,"NCT07326865","Hepatic Gene Response to Intravenous Glucose in Obese Patients With and Without MASLD Undergoing Bariatric Surgery","Glucose IV and Its Hepatic Outcomes After a Metabolic Stress Test During Bariatric Surgery in Obese Patients With and Without MASLD","GHAST","Inclusion Criteria:\n\nTo be eligible to participate in this study, a subject must meet all of the following criteria:\n\nAdult individuals, age \\>35 \\\u003C 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.\n\nFor obese non-MASLD patients:\n\n* Adult individuals, age \\>35 \\\u003C 65 years old.\n* BMI ≥ 40 kg\u002Fm², or a BMI ≥ 35 kg\u002Fm² with an obesity-related comorbidity\n* No MASLD based on Fibroscan\n* Estimated glomerular filtration rate (eGFR) \\> 60mL\u002Fmin\u002F1.73m2\n\nFor obese MASLD patients:\n\n* MASLD diagnosis according to Fibroscan\n* Compensated liver disease with the following hematologic and biochemical criteria on entry into study:\n\n  * ALAT \\\u003C10x ULN\n  * Hemoglobin \\> 11g\u002FdL for females and 12 g\u002FdL for males\n  * White blood cell (WBC) \\> 2.5 K\u002F μL\n  * Neutrophil count \\> 1.5 K μL\n  * Platelets \\> 100 K\u002FμL\n  * Total bilirubin \\\u003C35 μmol\u002FL\n  * Albumin \\>30 g\u002FL\n  * TP \\>80% or INR \\\u003C1.4\n  * Serum creatinine \\\u003C1.3 mg\u002FdL (men) or \\\u003C1.1 mg\u002FdL (women) or\n* Estimated glomerular filtration rate (eGFR) \\> 60mL\u002Fmin\u002F1.73m2\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Use of metformin and SGLT2\u002F exogenous insulin\u002FGLP-1 RA\n* Primary lipid disorder\n* Known genetic basis for insulin resistance or glucose intolerance\n* All medical and psychiatric conditions except for obesity related diseases.\n* Uncontrolled hypertension (RR \\> 150\u002F95 mmHg)\n* Chronic kidney disease (creatinine \\> 150 umol\u002FL)\n* Pregnancy, females who are breastfeeding\n* Evidence of another form of liver disease\n* History of sustained excess alcohol ingestion: daily consumption \\>30g\u002Fday (3 drinks per day) for males and \\>20 g\u002Fday (2 drinks per day) for females\n* 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\n* Body mass index (BMI) \\>45 kg\u002Fm2\n* Type 1 or type 2 diabetes\n* Hemostasis disorders or current treatment with anticoagulants\n* Known heart failure\n* Contra-indication for liver biopsy History of\u002For current cardiac dysrhythmias and\u002For a history of cardiovascular events including myocardial infarction, except patients with only well-controlled hypertension","ALL","35 Years","65 Years",{"count":87,"type":88},40,"ESTIMATED","INTERVENTIONAL",[91],"NA","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).\n\nThe main question is:\n\nDoes giving sugar directly into the vein change how liver genes work in people with and without MASLD?\n\nResearchers will compare:\n\n* People with MASLD who receive sugar\n* People with MASLD who receive saline (salt water)\n* People without MASLD who receive sugar\n* People without MASLD who receive saline\n\nDuring surgery, participants will:\n\n* Receive either a sugar solution (35 grams of glucose in 150 mL fluid) or saline\n* Have small samples (biopsies) taken from the liver and fat tissue before and 45 minutes after the infusion\n* Provide blood samples to measure sugar, insulin, and other metabolites\n* Provide a one-time sample of intestinal tissue that is normally removed during surgery\n\nThis 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.",[94],"MASLD",[96,97,98,99,100,101,102,103,104,105],"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","2025-12-25",{"date":108,"type":109},"2026-01-08","ACTUAL",{"date":111,"type":109},"2025-11-12",{"date":113,"type":88},"2027-05",{"name":5,"class":6},1]