[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654828":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":38,"interventions":51,"overallOfficials":26,"centralContacts":61,"locations":67,"responsibleParty":80,"collaborators":26,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":26,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":26,"studyType":97,"phases":98,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":69,"whyStopped":26,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Ain Shams University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Peak stimulated serum C-peptide concentration after mixed meal tolerance test","Peak stimulated serum C-peptide concentration after mixed meal tolerance test at 6 months (24 weeks) compared to baseline.","24 weeks",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Number of participants with treatment-related adverse events as assessed by CTCAE v6.0","Safety of verapamil during 24 weeks",{"measure":18,"description":19,"timeFrame":12},"HbA1c","HbA1c after 24 weeks compared to baseline",{"measure":21,"description":22,"timeFrame":12},"continuous glucose monitoring metrics (time in range) using freestyle libre2 plus CGM","Time in range using freestyle libre2 plus CGM at 24 weeks compared to baseline",{"measure":24,"description":25,"timeFrame":12},"coefficient of variation at 24 weeks compared to baseline using freestyle libre 2 CGM","CGM coefficient of variation at 24 weeks compared to baseline using freestyle libre 2 CGM",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":33},"QUADRUPLE",[34,35,36,37],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[39,45],{"label":40,"type":41,"description":42,"interventionNames":43},"Verapamil group","ACTIVE_COMPARATOR","Children and adolescents with newly diagnosed T1D on add on verapamil",[44],"Drug: Verapamil oral",{"label":46,"type":47,"description":48,"interventionNames":49},"placebo group","PLACEBO_COMPARATOR","Children and adolescents with newly diagnosed T1D on add on placebo",[50],"Drug: Placebo",[52,57],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":26},"DRUG","Verapamil oral","active comparator",[40],{"type":53,"name":58,"description":59,"armGroupLabels":60,"otherNames":26},"Placebo","placebo comparator",[46],[62],{"name":63,"role":64,"phone":65,"phoneExt":26,"email":66},"Nouran Salah, MD","CONTACT","+201116603336","nouranyousef@med.asu.edu.eg",[68],{"facility":5,"status":69,"city":70,"state":26,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":26},"RECRUITING","Cairo","11375","Egypt","EG",{"type":75,"coordinates":76},"Point",[77,78],31.24967,30.06263,{"lat":78,"lon":77},{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Nouran yousef","Dr","100654828","phase-2-oral-verapamil-among-newly-diagnosed-children-and-adolescents-with-type-1-diabetes-100654828",false,"NCT07804849","Oral Verapamil Among Newly Diagnosed Children and Adolescents With Type 1 Diabetes","Efficay and Safety of Oral Verapamil on Glycemic Metrics and ß-cell Reserve Among Newly Diagnosed Children and Adolescents With Type 1 Diabetes","Inclusion Criteria:\n\n* Children and adolescents aged 10-18 years.\n* Newly diagnosed type 1 diabetes mellitus (within 6 weeks of diagnosis, defined as the day of starting insulin therapy).\n* Presence of at least two positive islet autoantibody (anti glutamic acid decarboxylase antibodies, anti- tyrosine phosphataseantibodies ,anti- zinc transporter 8 protein antibodies , or anti-insulin antibodies).\n* Ability to comply with study procedures.\n\nExclusion Criteria:\n\n* Previous diagnosis of other endocrine disorders or autoimmune disorder (e.g. autoimmune thyroiditis).\n* Current or planned use of medications that might affect glucose metabolism (e.g., corticosteroids, immunomodulators).\n* Known allergy or intolerance to verapamil.\n* Cardiac conduction abnormalities, heart block, or significant cardiac disease.\n* Systolic or diastolic blood pressure \\\u003C 5th percentile for age and gender.\n* Severe hepatic or renal impairment.\n* Participation in another interventional clinical trial.\n* Inability to follow the protocol for any reason as determined by the investigator.\n* Elevated liver enzymes \\>1.5 × upper limit of normal at screening","ALL","10 Years","18 Years",{"count":95,"type":96},70,"ESTIMATED","INTERVENTIONAL",[99,100],"PHASE2","PHASE3","Type 1 diabetes (T1D) in children involves autoimmune destruction of pancreatic ß- cells, leading to insulin deficiency. Verapamil is an L-type calcium channel blocker that has been used for decades to treat hypertension and certain cardiac conditions. Recent research has revealed its potential as a ß- cell-protective agent. Hence this study will evaluate the effect of once-daily oral verapamil on pancreatic ß- cell reserve , glycemic metrics and daily insulin requirements in children and adolescents with T1D.",[103],"Type 1 Diabetes Mellitus",[105,106,107],"Type 1 diabetes","Verapamil","pancreatic reserve","2026-09-03",{"date":110,"type":111},"2026-09-04","ACTUAL",{"date":113,"type":96},"2026-08-20",{"date":115,"type":96},"2027-03-20",{"name":5,"class":6},1]