[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496998":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":34,"responsibleParty":91,"collaborators":93,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":100,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":10,"studyType":112,"phases":10,"briefSummary":113,"conditions":114,"keywords":10,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Royal Devon and Exeter NHS Foundation Trust","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early SU treatment",null,"Patients with permanent neonatal diabetes (PNDM) due to the V59M mutation in the KCNJ11 gene who commenced sulfonylurea therapy in the first twelve months of life.",[13],"Drug: Sulfonylurea",{"label":15,"type":10,"description":16,"interventionNames":17},"Late SU treatment","Patients with permanent neonatal diabetes (PNDM) due to the V59M mutation in the KCNJ11 gene who commenced sulfonylurea older than the age of twelve months.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DRUG","Sulfonylurea","Glibenlclamide \u002F glyburide",[9,15],[25],{"name":26,"affiliation":27,"role":28},"Prof Andrew Hattersley","University of Exeter \u002F Royal Devon University Healthcare Trust","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":10,"phoneExt":10,"email":33},"Dr Pamela Bowman, MBBS MSc PhD","CONTACT","P.Bowman@exeter.ac.uk",[35,52,65,78],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University of Chicago","RECRUITING","Chicago","Illinois","60637","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-87.65005,41.85003,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":10,"phoneExt":10,"email":10},"Maria Salguero Bermonth",{"facility":53,"status":37,"city":54,"state":10,"zip":10,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"University of Rome","Rome","Italy","IT",{"type":44,"coordinates":58},[59,60],12.51133,41.89193,{"lat":60,"lon":59},[63],{"name":64,"role":32,"phone":10,"phoneExt":10,"email":10},"Fabrizio Barbetti",{"facility":66,"status":37,"city":67,"state":10,"zip":10,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"University of Bergen","Bergen","Norway","NO",{"type":44,"coordinates":71},[72,73],5.32415,60.39299,{"lat":73,"lon":72},[76],{"name":77,"role":32,"phone":10,"phoneExt":10,"email":10},"Pernille Svalastoga",{"facility":79,"status":37,"city":80,"state":10,"zip":10,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"University of Exeter","Exeter","United Kingdom","UK",{"type":44,"coordinates":84},[85,86],-3.52751,50.7236,{"lat":86,"lon":85},[89],{"name":90,"role":32,"phone":10,"phoneExt":10,"email":10},"Pamela Bowman",{"type":92,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[94,95,96],{"name":36,"class":6},{"name":66,"class":6},{"name":97,"class":6},"University of Rome Tor Vergata","100496998","impact-of-sulphonylureas-on-neurodevelopmental-outcomes-in-kcnj11-related-intermediate-developmental-delay-epilepsy-and-neonatal-diabetes-idend-syndrome-100496998",false,"NCT05751525","Impact of Sulphonylureas on Neurodevelopmental Outcomes in KCNJ11-related Intermediate Developmental Delay, Epilepsy and Neonatal Diabetes (iDEND) Syndrome","Impact of Timing of Initiation of Sulphonylurea Therapy on Neurodevelopmental Outcomes in Individuals With Intermediate Developmental Delay, Epilepsy and Neonatal Diabetes (iDEND) Syndrome Due to the V59M Mutation in the KCNJ11 Gene","iDEND","Inclusion Criteria:\n\n* Current age ≥2 years\n* Heterozygous for a V59M mutation in the KCNJ11 gene\n* Successfully transferred to oral sulphonylurea therapy\n* Willing to participate\n\nExclusion Criteria:\n\n* Never able to transfer to oral sulphonylurea therapy\n* Unwilling to participate","ALL","2 Years","50 Years",{"count":110,"type":111},21,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn about the impact of the diabetes drug glibenclamide (glyburide) on neurodevelopment in individuals with iDEND (developmental delay, epilepsy and neonatal diabetes) due to the V59M mutation in the KCNJ11 gene. The main question it aims to answer is whether initiating sulphonylurea (SU) therapy in the first year of life results in better neurodevelopmental outcomes in affected individuals, in comparison to starting therapy later than 12 months of age.\n\nParticipants will undergo a neurodevelopmental assessment comprising parental and teacher completion of standardised questionnaires, and where possible face to face neuropsychological testing.\n\nResearchers will compare the outcomes of these standardised tests in the individuals who started SU therapy \\\u003C12 months of age in comparison to those who started \\>12 months of age.",[115,116,117,118,119,120],"Neurodevelopmental Disorders","Intellectual Disability","Development Delay","ADHD","Autism Spectrum Disorder","Epilepsy","2024-06-11",{"date":123,"type":124},"2024-06-13","ACTUAL",{"date":126,"type":124},"2016-07-01",{"date":128,"type":111},"2025-12-31",{"name":5,"class":6},4]