[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bile-acid-elevated-serum\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bile-acid-elevated-serum":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100587254","early-phase-1-metabolic-effects-of-endogenous-bile-acids-after-gastric-bypass-surgery-100587254",false,"NCT06925997","Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery","Bile-bar","Inclusion Criteria:\n\nIntervention group\n\n* RYGB-operated ≥ 18 months prior to inclusion\n* History of diabetes prior to RYGB (HbA1c ≥48 mmol\u002Fmol or use of antidiabetic medication)\n* HbA1c \\\u003C58 mmol\u002Fmol on no antidiabetic medication or metformin alone\n* Weight change \\\u003C ±3 kg for \\>3 months at time of inclusion\n\nControl group A\n\n* No history of diabetes\n* HbA1c \\\u003C48 mmol\u002Fmol at time of inclusion\n* Fasting plasma glucose \\\u003C 7.0 mmol\u002FL at time of inclusion\n* Weight change \\\u003C ±3 kg for \\>3 months at time of inclusion Control group B\n* Type 2 diabetes (HbA1c ≥48 mmol\u002Fmol or use of antidiabetic medication at time of inclusion)\n* Weight change \\\u003C ±3 kg for \\>3 months at time of inclusion\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Haemoglobin \\\u003C 6.5 mmol\u002FL at time of inclusion\n* Fasting plasma glucose \\> 10.0 mmol\u002FL at time of inclusion\n* Prior cholecystectomy\n* Chronic or tendency to diarrhoea",true,"ALL","18 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","Non-randomized, open-label, parallel-group clinical study evaluating the effects of endogenous bile acids on changes in plasma fibroblast growth factor-19 (FGF-19) and glucose metabolism by extended depletion of circulating bile acids using colesevelam as an experimental tool in subjects operated with gastric by-pass (RYGB).",[27,28,29],"Bariatric Surgery Candidate","Bile Acid, Elevated Serum","Glucose Metabolism Disorders","RECRUITING","2025-04-11",{"date":33,"type":34},"2025-04-13","ACTUAL",{"date":36,"type":34},"2024-05-02",{"date":38,"type":21},"2028-12",{"name":40,"class":41},"Hvidovre University Hospital","OTHER"]