[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646405":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":57,"collaborators":20,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":20,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":20,"enrollmentInfo":70,"targetDuration":20,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":89,"whyStopped":20,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Rhode Island Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Arm","EXPERIMENTAL","verapamil hydrochloride",[13],"Drug: Verapamil Hydrochloride",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Verapamil Hydrochloride","Verapamil extended release (ER) will be initiated at a dose of 120mg daily and up-titrated over six weeks to target dose of 360mg daily as tolerated.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Kevin J Scully","CONTACT","401-444-5504","kevin_scully@brown.edu",[28,46],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Diabetes Research Center, Massachusetts General Hospital","Boston","Massachusetts","02114","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-71.05977,42.35843,{"lat":39,"lon":38},[42],{"name":43,"role":24,"phone":44,"phoneExt":20,"email":45},"Melissa Putman","617-726-8722","msputman@mgh.harvard.edu",{"facility":5,"status":20,"city":47,"state":48,"zip":49,"country":33,"countryCode":34,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"Providence","Rhode Island","02903",{"type":36,"coordinates":51},[52,53],-71.41283,41.82399,{"lat":53,"lon":52},[56],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Kevin Scully","Principle Investigator; Pediatric Endocrinologist","100646405","phase-2-verapamil-effect-in-cystic-fibrosis-related-dysglycemia-100646405",false,"NCT07688070","Verapamil Effect in Cystic Fibrosis-related Dysglycemia","The Effect of Verapamil on Beta Cell Function in Adolescents and Adults With Cystic Fibrosis-related Dysglycemia","Inclusion Criteria:\n\n1. Age 14 years and older\n2. Genetically-confirmed diagnosis of cystic fibrosis\n3. Clinical diagnosis of pancreatic insufficiency, defined as requiring pancreatic enzyme replacement therapy (PERT)\n4. Diagnosis of AGT or CFRD within 3-months of study enrollment\n\n   1. AGT is defined as having either a OGTT 2-hour glucose \\>140 mg\u002FdL and \\\u003C200 mg\u002FdL or OGTT 1-hour glucose \\>200 mg\u002FdL\n   2. CFRD is defined as having a fasting glucose \\>126 mg\u002FdL and\u002For OGTT 2-hour glucose \\>200 mg\u002FdL\n5. Willing to attempt to maximize verapamil to the goal study dosage of 360 mg PO daily\n6. If taking elexacaftor\u002Ftezacaftor\u002Fivacaftor (ETI), willing to adjust dosing\n\nExclusion Criteria:\n\n1. Severe lung disease indicated by forced expiratory volume in 1 second (FEV1) \\\u003C50% predicted on most recent spirometry testing\n2. Body mass index (BMI) \\\u003C18 kg\u002Fm2\n3. Weight \\\u003C50 kg\n4. Current or planned pregnancy within the next 6 months\n5. Treatment with IV antibiotics for a CF exacerbation within 1 month\n6. Systemic supraphysiologic glucocorticoid use within 1 month\n7. Initiation or discontinuation of a CFTR modulator within 3 months (i.e. recent change in CFTR modulator formulation\u002Fusage)\n8. Current use of insulin, a GLP-1 receptor agonist, or oral anti-diabetic agent\n9. Most recent HbA1c \\>7%\n10. Not taking a CFTR modulator due to genotype-ineligibility\n11. Current use of vanzacaftor\u002Ftezacaftor\u002Fdeutivcaftor\n12. Known hypersensitivity to verapamil\n13. Blood pressure (BP) \\\u003C90\u002F60 (adults) or \\\u003C5th centile for age and gender (youth) in 2 out of 3 measurements\n14. Heart rate (HR) \\\u003C60 bpm (adults) or \\\u003C2nd centile for age and gender (youth) in 2 out of 3 measurements\n15. History of previously diagnosed vasovagal syncopal episodes related to hypotension\n16. History of significant cardiac disease (e.g. severe ventricular dysfunction, hypertrophic cardiomyopathy)\n17. History of certain arrhythmias (e.g. AV block, accessory pathway such as Wolff-Parkinson-White or Lown-Ganong-Levine syndromes)\n18. Abnormal liver function tests defined as AST or ALT \\>1.5 upper limit of normal \\[ULN\\] at the time of screening, or end stage cirrhosis\n19. End stage renal disease on dialysis\n20. History of Duchenne's muscular dystrophy\n21. Need for the use of any pertinent medications (beta blockers, carbamazepine, phenobarbital, phenytoin, HMG-CoA reductase inhibitors, lithium, theophylline, clonidine).\n22. Allergy to any of the components of the MMTT standardized meal","ALL","14 Years",{"count":71,"type":72},30,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","The investigators are conducting a pilot open-label pre\u002Fpost interventional trial in adolescents and adults with cystic fibrosis (CF) and abnormal glucose tolerance or early CF-related diabetes mellitus (CFRD) to assess the safety and efficacy of verapamil on beta cell function and dysglycemia.",[78,79,80],"Cystic Fibrosis Related Diabetes","Cystic Fibrosis (CF)","Abnormal Glucose Tolerance",[82,83,84,85,86,87,88],"cystic fibrosis related diabetes","mixed meal tolerance test","verapamil","beta cell function","continuous glucose monitoring","abnormal glucose tolerance","cystic fibrosis","NOT_YET_RECRUITING","2026-07-07",{"date":92,"type":93},"2026-07-09","ACTUAL",{"date":95,"type":72},"2026-08-01",{"date":97,"type":72},"2028-08-31",{"name":5,"class":6},2]