[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587254":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":29,"responsibleParty":46,"collaborators":11,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":11,"enrollmentInfo":59,"targetDuration":11,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":11,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Hvidovre University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"3.75 mg Colesevelam in 8 weeks","EXPERIMENTAL",null,[13],"Drug: Colesevelam",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Colesevelam","Colesevelam is an approved drug with well known adverse events. Gastrointestinal side effects (Obstipation, flatulence, abdominal pain, diarrhea, nausea, meteorism, vomiting, chanced faeces) are very common (\\>10%) or common (1-10%), but are mild and tolerable in most cases. All participants will be monitored closely, and colesevelam will be discontinued if the subject experience unreserved adverse events. All effects of colesevelam are transient (17-19) as the compound is not absorbed to the systemic circulation, i.e. treatment effects cease when the drug is excreted from the intestine. Specifically, no permanent metabolic effects of colesevelam has been observed in crossover experiments (27). Therefore, 8 weeks of colesevelam treatment as planned in the current study will have no long lasting positive or negative effects on the participants.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Marie-Louise Dichman","CONTACT","+4526710371","marie-louise.dichman@regionh.dk",{"name":27,"role":23,"phone":11,"phoneExt":11,"email":28},"Carsten Dirksen","carsten.dirksen@regionh.dk",[30],{"facility":31,"status":32,"city":33,"state":11,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre","RECRUITING","Hvidovre","2650","Denmark","DK",{"type":38,"coordinates":39},"Point",[40,41],12.47708,55.64297,{"lat":41,"lon":40},[44,45],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},{"name":27,"role":23,"phone":11,"phoneExt":11,"email":28},{"type":47,"investigatorFullName":22,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Principal investigator, MD, Ph.D. student","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":60,"type":61},18,"ESTIMATED","INTERVENTIONAL",[64],"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).",[67,68,69],"Bariatric Surgery Candidate","Bile Acid, Elevated Serum","Glucose Metabolism Disorders","2025-04-11",{"date":72,"type":73},"2025-04-13","ACTUAL",{"date":75,"type":73},"2024-05-02",{"date":77,"type":61},"2028-12",{"name":5,"class":6},1]