[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494317":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":51,"collaborators":54,"id":65,"slug":11,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":11,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":91,"whyStopped":11,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Vastra Gotaland Region","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Once-daily dual-release hydrocortisone","EXPERIMENTAL",null,[13],"Drug: OD dual-release Hydrocortisone",{"label":15,"type":16,"description":11,"interventionNames":17},"Thrice-daily conventional immediate-release hydrocortisone","ACTIVE_COMPARATOR",[18],"Drug: TID Hydrocortisone",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","OD dual-release Hydrocortisone","Treatment with once-daily dual-release hydrocortisone",[9],[9],{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"TID Hydrocortisone","Treatment with thrice-daily conventional immediate-release hydrocortisone",[15],[15],[32],{"name":33,"affiliation":34,"role":35},"Dimitrios Chantzichristos, MD PhD","Sahlgrenska University Hospital","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":11,"email":40},"CONTACT","+46313428547","dimitrios.chantzichristos@gu.se",[42],{"facility":34,"status":11,"city":43,"state":11,"zip":11,"country":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":11},"Gothenburg","Sweden",{"type":46,"coordinates":47},"Point",[48,49],11.96679,57.70716,{"lat":49,"lon":48},{"type":35,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"DimitriosChantzichristos","Principal Investigator",[55,58,61,62],{"name":56,"class":57},"The Swedish Society of Medicine","OTHER",{"name":59,"class":60},"Åke Wibergs Stiftelse","UNKNOWN",{"name":34,"class":57},{"name":63,"class":64},"Pilloxa","INDUSTRY","100494317",false,"NCT05716607","Treatment Study in Patients Treated With Both Insulin & Hydrocortisone","Randomized Cross-over Trial in Patients Treated With Both Insulin & Hydrocortisone","INSCORT","Inclusion Criteria:\n\nMen and women at age 18 to 70 years, with BMI 18-32 kg\u002Fm2 and well-defined both insulin-treated diabetes \\& Addison's disease for \\>12 months each, on insulin treatment and stable hydrocortisone replacement with once-daily dual-release hydrocortisone (20-30 mg\u002Fday) for \\>3 months.\n\nExclusion Criteria:\n\n* Any medication with other glucose lowering agents than insulin\n* Any additional underlying or intercurrent disease that may need regular or periodic pharmacological treatment with glucocorticoids during the study period, including infectious diseases\n* Any medication with agents which in the investigator's judgement might interfere with the study drugs kinetics, including therapies affecting gastrointestinal emptying or motility\n* Any medication with oral estrogen supplementation and\u002For regular DHEA medication for the past 4 weeks\n* Clinically significant renal dysfunction with a serum creatinine above 160 mmol\u002FL\n* Active malignancy\n* Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, hepatobiliary\u002Fpancreatic disease which in the investigator's judgement may interfere with the study assessment\n* Pregnant or lactating women\n* Alcohol\u002Fdrug abuse or any other condition associated with poor patient compliance, including expected non-cooperation, as judged by the investigator.","ALL","18 Years","70 Years",{"count":76,"type":77},16,"ESTIMATED","INTERVENTIONAL",[80],"NA","The aim of INS.CORT trial is, by studying glycemic variability in a well-defined patient group with both insulin \\& hydrocortisone (patients with concomitant insulin-treated diabetes \\& Addison's disease) and collecting information about the administration -time point and doses- of insulin, hydrocortisone and food intake with the help of new technology to improve the treatment in all patients treated with both insulin \\& glucocorticoids.",[83,84,85],"Diabetes Mellitus","Adrenal Insufficiency","Polyglandular Autoimmune Syndrome",[87,88,89,90],"Insulin treatment","Hydrocortisone treatment","Opposing effects on glucose metabolism","Randomized Controlled Trial","NOT_YET_RECRUITING","2024-04-28",{"date":94,"type":95},"2024-04-30","ACTUAL",{"date":97,"type":77},"2024-09",{"date":99,"type":77},"2027-12",{"name":5,"class":6},1]