[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600788":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":29,"responsibleParty":52,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":10,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"CFRD F508del +ETI",null,"CFRD with at least one copy of F508del currently on elexacaftor\u002Ftezacaftor\u002Fivacaftor (CFRDF508del+ETI),",{"label":13,"type":10,"description":14,"interventionNames":10},"CFRD-ETI","CFRD with a mutation that is not eligible for modulator therapy (CFRD-ETI).",[16],{"name":17,"affiliation":18,"role":19},"Rita Basu, MD","UAB Medicine","PRINCIPAL_INVESTIGATOR",[21,25],{"name":17,"role":22,"phone":23,"phoneExt":10,"email":24},"CONTACT","205-934-1200","rbasu@uabmc.edu",{"name":26,"role":22,"phone":27,"phoneExt":10,"email":28},"Ananda Basu, MD","205-934-1202","anandabasu@uabmc.edu",[30],{"facility":5,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Birmingham","Alabama","352294","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-86.80249,33.52066,{"lat":41,"lon":40},[44,48],{"name":45,"role":22,"phone":46,"phoneExt":10,"email":47},"Tavares R Donerlson, BA","2054848306","Tdonerlson@uabmc.edu",{"name":49,"role":22,"phone":50,"phoneExt":10,"email":51},"John M Mullin, BS","2672290194","jmmullin@uabmc.edu",{"type":19,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Rita Basu","Endowed Professor of Diabetes Science",[56],{"name":57,"class":58},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100600788","glucose-metabolism-in-cystic-fibrosis-related-diabetes-cfrd-100600788",false,"NCT07102043","Glucose Metabolism in Cystic Fibrosis Related Diabetes (CFRD)","Glucose Metabolism in CFRD: Exploring the Role of CFTR Modulators in Metabolic Dysfunction","Inclusion Criteria:\n\n1. Diagnosis of Cystic Fibrosis Related Diabetes (CFRD)\n2. Age 21-75 years at time of consent\n3. BMI 19-50 kg\u002Fm2 (In Asians BMI is \\~ 2 points lower for comparison so it is 17-48 kg\u002Fm2)\n4. Creatinine ≤ 1.4 mg\u002Fdl in women and ≤ 1.5 mg\u002Fdl in men\n5. HbA1c ≤ 11% lifestyle treatment or mono\u002Fcombination therapy with oral hypoglycemic agents (e.g. metformin or sulphonylurea or SGLT2i) and preferably on insulin pump therapy (i.e., SAP, HCL) with or without CGM will be recruited. However, use of MDI (Multiple Daily Injections) of insulin, i.e., on basal-bolus insulin therapy will also be included. Most of our patients are on insulin therapy with very few on oral antidiabetes medications but we would like to offer them the choice of participation.\n6. Subjects on FDA approved\u002Frecommended full doses of ETI will be offered participation. If dose adjustments of ETI are made after enrollment a discussion will be done with the primary care provider and HCSTOC as required.\n7. Willing to be at a stable weight for duration of the study.\n8. An understanding of and willingness to follow the protocol and sign the informed consent\n\nSubjects meeting any of the exclusion criteria at baseline will be excluded from study participation:\n\nExclusion Criteria:\n\n1. Debilitating chronic disease\n2. Anemia \\\u003C10.0 gm\u002FdL in females and \\\u003C11.0 gm\u002FdL in males\n3. Symptoms of undiagnosed illness on history\u002Fexam\n4. Abuse of alcohol or recreational drugs\n5. Pregnancy\n6. Active hepatic disease (we will include only if less than 3X ULN for liver enzymes and no fibrosis on ultrasound). Transient elevations of liver enzymes will not exclude participation but will be discussed with the primary care provider and HCSTOC as required.\n7. Current use of the following drugs and supplements:\n\n   i. Corticosteroids ii. Benzodiazepines iii. Opiates iv. Barbiturates v. Anticoagulant therapy vi. Any other medication that the investigator believes is a contraindication to the subject's participation","ALL","21 Years","75 Years",{"count":70,"type":71},30,"ESTIMATED","OBSERVATIONAL","The study aims to test whether use of CFTR modulators (ETI) improves fasting and post prandial glycemia by enhancing disposition index (DI) in individuals with CFRD with CFTR +ve mutation (at least one copy of F508del) on CFTR modulator (ETI) therapy (CFRDF508del+ETI). CFRD with a mutation that is not eligible for modulator therapy (CFRD-ETI) will be the control group.",[75],"Cystic Fibrosis Related Diabetes",[75,77,78,79],"cystic fibrosis transmembrane conductance regulator (CFTR)","CFTR modulators","Elexacaftor\u002F tezacaftor\u002Fivacaftor or ETI","2026-06-19",{"date":82,"type":83},"2026-06-24","ACTUAL",{"date":85,"type":83},"2026-05-28",{"date":87,"type":71},"2028-05-28",{"name":5,"class":6},1]