[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651335":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":43,"centralContacts":47,"locations":30,"responsibleParty":52,"collaborators":30,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":30,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":78,"overallStatus":89,"whyStopped":30,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":30},{"fullName":5,"class":6},"Vanderbilt University Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Bariatric Surgery Participants Undergoing Metabolic Flux Assessment","EXPERIMENTAL","Adults scheduled and clinically cleared for protocol-eligible bariatric surgery at VUMC will undergo research MRI\u002FMRE, blood collection, non-radioactive stable isotope tracer infusions, and intraoperative research tissue collection during planned bariatric surgery, followed by repeat noninvasive metabolic assessment approximately 6 months after surgery.",[13,14,15,16],"Procedure: Bariatric surgery","Other: Stable isotope tracer infusion","Diagnostic Test: MRI\u002FMRE","Procedure: Research tissue collection during planned bariatric surgery",[18,26,31,39],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"PROCEDURE","Bariatric surgery","Clinically indicated bariatric surgery, such as Roux-en-Y gastric bypass or sleeve gastrectomy, performed as part of standard clinical care.",[9],[24,25],"Roux-en-Y-gastric byass","sleeve gastrectomey",{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Stable isotope tracer infusion","Intravenous non-radioactive stable isotope tracers administered for research measurement of metabolic flux: \\[¹³C₃\\]lactate, \\[6,6-²H₂\\]-D-glucose, and \\[9,9-²H₂\\]palmitate.",[9],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DIAGNOSTIC_TEST","MRI\u002FMRE","Abdominal MRI proton density fat fraction and magnetic resonance elastography to assess hepatic fat and stiffness before surgery and approximately 6 months after surgery.",[9],[37,38],"magnetic resonance imaging","magnetic resonance elastography",{"type":19,"name":40,"description":41,"armGroupLabels":42,"otherNames":30},"Research tissue collection during planned bariatric surgery","Liver, omentum, subcutaneous adipose tissue, and skeletal muscle specimens collected only during clinically planned bariatric surgery and only if safe in the surgeon's judgment.",[9],[44],{"name":45,"affiliation":5,"role":46},"Charles R Flynn, PhD","PRINCIPAL_INVESTIGATOR",[48],{"name":45,"role":49,"phone":50,"phoneExt":30,"email":51},"CONTACT","615-343-8329","MASLD.research@vumc.org",{"type":46,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Charles R. Flynn","Associate Professor","100651335","metabolic-flux-analysis-in-metabolic-dysfunction-associated-steatotic-liver-disease-100651335",false,"NCT07760909","Metabolic Flux Analysis in Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Flux Analysis in MASLD","MASLD","Inclusion Criteria:\n\n* Scheduled and clinically cleared for protocol-eligible bariatric surgery at Vanderbilt University Medical Center.\n* BMI ≥40 kg\u002Fm², or BMI \\>35 kg\u002Fm² with at least one obesity-associated comorbidity, such as type 2 diabetes, cardiovascular disease, hypertension, hyperlipidemia, obstructive sleep apnea, MASLD, osteoarthritis, or polycystic ovarian syndrome.\n* Able and willing to complete study procedures, including informed consent, questionnaires, blood draws, MRI\u002FMRE imaging, stable isotope tracer infusion, and research tissue collection during planned bariatric surgery.\n* Able to provide informed consent in English.\n\nExclusion Criteria:\n\n* Contraindication to MRI\u002FMRE, including implanted cardiac defibrillator, pacemaker, or other MRI-incompatible implanted device.\n* Prior gastric or intestinal surgery, pancreatic surgery, or other prior surgery that, in the judgment of the study team or bariatric surgeon, would interfere with study procedures or outcome interpretation.\n* Active cancer or ongoing cancer treatment.\n* Presence or history of HIV infection.\n* Alcohol use above study-defined limits: more than 14 alcoholic drinks per week for men or more than 7 alcoholic drinks per week for women, or illicit drug use that would interfere with safe participation or interpretation of study results.\n* Anemia or other hematologic condition that would increase risk from study blood collection.\n* Abnormal ECG or clinically significant cardiovascular finding that would increase risk from study procedures.\n* Impaired renal function or other clinically significant condition that would increase risk from study participation.\n* Known Wilson's disease, alpha-1 antitrypsin deficiency, hemochromatosis, or other non-MASLD chronic liver disease that would confound interpretation of study outcomes.\n* Any medical, surgical, or safety condition that, in the judgment of the PI, clinical co-investigator, CRC staff, anesthesia team, or bariatric surgeon, would make participation unsafe or interfere with completion of study procedures.","ALL","21 Years","70 Years",{"count":67,"type":68},20,"ESTIMATED","INTERVENTIONAL",[71],"NA","This prospective, single-center pilot study will evaluate metabolic flux dysregulation in adults with obesity and suspected or confirmed metabolic dysfunction-associated steatotic liver disease (MASLD) who are scheduled for protocol-eligible bariatric surgery at Vanderbilt University Medical Center. Participants will undergo research assessments before surgery, during the planned bariatric surgery encounter, and approximately 6 months after surgery. The study uses non-radioactive stable isotope tracer infusions, serial blood sampling, abdominal MRI\u002FMRE, and research tissue specimens collected only during clinically planned bariatric surgery to quantify hepatic and extrahepatic metabolic fluxes. The primary objective is to determine how hepatic citric acid cycle flux and related metabolic pathways change after bariatric surgery and how these metabolic measures relate to liver fat, liver stiffness, and biopsy-graded MASLD\u002FMASH severity.",[74,75,76,77],"Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Dysfunction-Associated Steatohepatitis","Obesity","Bariatric Surgery",[61,79,80,81,82,83,84,85,38,86,87,88],"MASH","metabolic flux analysis","stable isotope tracer","bariatric surgery","Roux-en-Y gastric bypass","sleeve gastrectomy","liver fat","citric acid cycle","gluconeogenesis","free fatty acid turnover","NOT_YET_RECRUITING","2026-08-07",{"date":92,"type":93},"2026-08-12","ACTUAL",{"date":95,"type":68},"2026-10-01",{"date":97,"type":68},"2060-01-01",{"name":5,"class":6}]