[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650369":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":65,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":26,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":103,"whyStopped":26,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Hospital das Clínicas de Ribeirão Preto","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Roux-en-Y Gastric Bypass Group","EXPERIMENTAL","Participants scheduled for clinically indicated laparoscopic RYGB receive a single oral research dose of rosuvastatin 10 mg plus losartan 25 mg within 30 days before surgery and again approximately 12 weeks after surgery. Plasma is collected at 0, 1.5, and 4 hours at each visit. Paired stool samples are collected before and after surgery for microbiome and untargeted metabolomics analyses.",[13,14],"Drug: Rosuvastatin","Drug: Losartan (Control)",{"label":16,"type":17,"description":18,"interventionNames":19},"Sleeve Gastrectomy Group","ACTIVE_COMPARATOR","Participants scheduled for clinically indicated laparoscopic sleeve gastrectomy receive the same single oral research doses and pharmacokinetic plasma sampling schedule before and approximately 12 weeks after surgery. Stool collection and microbiome\u002Fmetabolomics analyses are not performed in this group.",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Rosuvastatin","Rosuvastatin 10 mg tablet, single oral dose at each of two pharmacokinetic visits. Other name: rosuvastatin calcium.",[9,16],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Losartan (Control)","Losartan 25 mg tablet, single oral dose at each of two pharmacokinetic visits. Other name: losartan potassium.",[9,16],[32],{"name":33,"affiliation":34,"role":35},"Wilson Salgado Jr, MD PhD","Medical School of Ribeirao Preto, University of Sao Paulo","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Wilson Salgado Jr, MD, PhD","CONTACT","+5516981564846","wsalgado@fmrp.usp.br",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Joao A Ferreira-Filho, MD","+5516988250557","joaoalmiroff@gmail.com",[47],{"facility":48,"status":26,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Hospital das Clínicas, Ribeirão Preto Medical School, University of São Paulo","Ribeirão Preto","São Paulo","14048900","Brazil","BR",{"type":55,"coordinates":56},"Point",[57,58],-47.81028,-21.1775,{"lat":58,"lon":57},[61],{"name":62,"role":39,"phone":63,"phoneExt":26,"email":64},"Fabiana CP Valera, MD PhD","+5516981548312","facpvalera@fmrp.usp.br",{"type":66,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[68],{"name":69,"class":70},"School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo","UNKNOWN","100650369","rosuvastatin-and-losartan-pharmacokinetics-after-bariatric-surgery-100650369",false,"NCT07748273","Rosuvastatin and Losartan Pharmacokinetics After Bariatric Surgery","Comparative Evaluation of Rosuvastatin and Losartan Pharmacokinetics and the Associations Between Gut Microbiota Alterations and Changes in Systemic Drug Exposure in Patients Undergoing Roux-en-Y Gastric Bypass or Sleeve Gastrectomy","BARI-PK","Inclusion Criteria:\n\n* Adults aged 18 to 65 years;\n* Formal clinical indication for RYGB or sleeve gastrectomy after multidisciplinary assessment;\n* Bariatric surgery scheduled and no previous bariatric procedure;\n* Able to understand the study and provide written informed consent.\n\nExclusion Criteria:\n\n* Moderate or severe hepatic impairment, liver enzymes greater than 3 times the upper limit of normal, or Child-Pugh class B or C.\n* Estimated glomerular filtration rate below 30 mL\u002Fmin\u002F1.73 m².\n* Concomitant use of drugs that substantially affect rosuvastatin pharmacokinetics and cannot be temporarily discontinued, including cyclosporine, gemfibrozil, or potent OATP1B1\u002FBCRP or CYP2C9 inhibitors.\n* Systemic antibiotic use within 3 months or probiotic, prebiotic, or synbiotic use within 4 weeks before sampling.\n* Continuous current rosuvastatin or other statin therapy unless medically discontinued with an adequate washout period under physician supervision.\n* Clinically relevant baseline hypotension, significant hyperkalemia, renal impairment, or another condition that makes a losartan test dose unsafe.\n* Severe postoperative complication preventing oral dosing, including active gastrointestinal leak, intractable vomiting, or severe anastomotic stenosis.\n* Pregnancy. Participants of childbearing potential undergo routine preoperative beta-hCG testing.","ALL","18 Years","65 Years",{"count":83,"type":84},60,"ESTIMATED","INTERVENTIONAL",[87],"NA","This prospective, open-label, non-randomized pharmacokinetic study will evaluate how Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy affect systemic exposure to single oral test doses of rosuvastatin and losartan. Sixty adults scheduled for bariatric surgery will enter one of two parallel groups according to the clinically selected operation (30 RYGB and 30 sleeve gastrectomy). Each participant will receive rosuvastatin 10 mg and losartan 25 mg once within 30 days before surgery and again approximately 12 weeks after surgery. Plasma samples collected before dosing and at 1.5 and 4 hours after dosing will be used with maximum a posteriori Bayesian estimation to estimate individual pharmacokinetic parameters. In the 30-participant RYGB group only, paired stool samples will be used to explore gut microbiota and untargeted fecal metabolomic changes. The primary objective is to compare within-participant changes and between-procedure differences in drug exposure after bariatric surgery.",[90,91,92,93],"Obesity & Overweight","Bariatric Surgery","Pharmacokinetics After Oral Intake","Drug Absorption",[95,96,97,98,99,100,101,102],"Roux-en-Y gastric bypass","sleeve gastrectomy","rosuvastatin","losartan","E-3174","gut microbiota","metabolomics","systemic exposure","NOT_YET_RECRUITING","2026-08-03",{"date":106,"type":107},"2026-08-05","ACTUAL",{"date":109,"type":84},"2026-08-02",{"date":111,"type":84},"2027-05-15",{"name":5,"class":6},1]