[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"abnormal-glucose-tolerance\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:abnormal-glucose-tolerance":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"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":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"Cystic Fibrosis Related Diabetes","Cystic Fibrosis (CF)","Abnormal Glucose Tolerance",[30,31,32,33,34,35,36],"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":40,"type":41},"2026-07-09","ACTUAL",{"date":43,"type":20},"2026-08-01",{"date":45,"type":20},"2028-08-31",{"name":47,"class":48},"Rhode Island Hospital","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":5},"100418635","phase-2-glp-1-agonist-therapy-in-cystic-fibrosis-related-glucose-intolerance-100418635","NCT04731272","GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance","Effect of GLP-1 Agonist Therapy on Insulin Secretion in Adults With Pancreatic Insufficient Cystic Fibrosis and Abnormal Glucose Tolerance: a Randomized, Open-label, Cross-over Trial","Inclusion Criteria:\n\n* 1\\. Male or female, aged ≥18 years on date of consent\n* 2\\. Confirmed diagnosis of CF, defined by positive sweat test or Cystic Fibrosis transmembrane conductance regulator (CFTR) mutation analysis according to Cystic Fibrosis Foundation (CFF) diagnostic criteria.\n* 3\\. Pancreatic insufficiency defined by clinical requirement for pancreatic enzyme replacement.\n* 4\\. Abnormal glucose tolerance defined by OGTT criteria for EGI, IGT, or CFRD, or diagnosed CFRD.\n\n  1. There will be no restriction on enrollment of individuals with CFRD but without fasting hyperglycemia (fasting hyperglycemia is defined as fasting glucose ≥126 mg\u002FdL)\n  2. Individuals with CFRD and fasting hyperglycemia (defined as above or by the use of basal insulin therapy) must also have a HbA1c ≤8% and a random (non-fasting) C-peptide ≥1.2 ng\u002FmL17; enrollment of this subgroup will be limited to n =10.\n* 5\\. Ability to take subcutaneous medication and be willing to adhere to the weekly administration regimen and complete study specific procedures (MMTT)\n* 6\\. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 weeks after the end of dulaglutide or observation administration; oral contraceptives, intra-uterine devices, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable\n\nExclusion Criteria:\n\n* 1\\. BMI \\\u003C19 kg\u002Fm2\n* 2\\. Presence of first-degree atrioventricular block or other evidence for cardiac conduction system or structural heart defects\n* 3\\. Pregnancy or lactation; a negative urine pregnancy test will be required at enrollment\n* 4\\. Known allergic reactions to any GLP-1 agonist, and any history of severe hypersensitivity reactions (anaphylaxis or angioedema)\n* 5\\. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 (MEN2)\n* 6\\. Pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks prior to study procedures\n* 7\\. Gastrointestinal symptom exacerbation defined by current nausea\u002Fvomiting or diarrhea\n* 8\\. Established diagnosis of non-CF diabetes (e.g. type 1 diabetes) or CFRD with fasting hyperglycemia (fasting glucose ≥126 mg\u002FdL \\[use of prandial insulin or repaglinide will be permitted\\])\n* 9\\. History of clinically symptomatic pancreatitis within the last year\n* 10\\. Prior lung, liver or other solid organ transplant\n* 11\\. Severe CF liver disease, as defined by the presence of portal hypertension\n* 12\\. History of fundoplication-related dumping syndrome\n* 13\\. Hemoglobin \\\u003C10 g\u002FdL, within 90 days of study procedures or at screening\n* 14\\. Abnormal renal function, within 90 days of study procedures or at screening; defined as creatinine \\>2x upper limit of normal (ULN) or potassium \\>5.5mEq\u002FL on non-hemolyzed specimen\n* 15\\. History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk to the subject","18 Years",{"count":19,"type":20},[23],"Diabetes is a major co-morbidity in pancreatic insufficient cystic fibrosis (PI-CF) and associated with worse outcomes. While reduced β-cell mass contributes to the insulin secretory defects that characterizes cystic fibrosis-related diabetes (CFRD), other modifiable determinants appear operative in the emergence and progression of abnormal glucose tolerance towards diabetes. Identifying interventions to preserve β-cell function are crucial for delaying and potentially preventing CFRD development. In this study, we hypothesize that weekly administration of the long-acting glucagon-like peptide-1 (GLP-1) agonist dulaglutide will improve defective early-phase insulin secretion and improve glucose tolerance during a mixed-meal tolerance test.",[61,62,28,63],"Cystic Fibrosis","Pancreatic Insufficiency","Diabetes",[26,65,66,67],"Glucose Intolerance","Insulin Secretion","Glucagon-Like Peptide-1 (GLP-1)","RECRUITING","2026-05-13",{"date":71,"type":41},"2026-05-18",{"date":73,"type":41},"2021-07-16",{"date":75,"type":20},"2028-06-30",{"name":77,"class":48},"University of Pennsylvania"]