[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100197851":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":63,"collaborators":65,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":25,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":25,"enrollmentInfo":78,"targetDuration":25,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"University of Pennsylvania","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GLP-1 Incretin Hormone","EXPERIMENTAL","The incretin, Glucagon-Like-peptide-1 (GLP-1) will be infused into the veins starting 30 minutes prior to initiating the GPA test. This infusion will continue for a total of 90 mins. (during the GPA for 230 mg\u002FdL glucose levels) and then this will be stopped. The GPA test will be performed for the 340 mg\u002FdL glucose levels but no incretin will be infused during this part of the test. These data will be compared when the subject repeats the GPA test with a placebo (saline or salt containing solution) infusion.",[13],"Drug: GLP-1",{"label":15,"type":10,"description":16,"interventionNames":17},"GIP Incretin Hormone","The incretin, Glucose-dependent Insulinotropic Polypeptide (GIP) will be infused into the veins starting 30 minutes prior to initiating the GPA test. This infusion will continue for a total of 90 mins (during the GPA for 230 mg\u002FdL glucose levels) and then this will be stopped. The GPA test will be performed for the 340 mg\u002FdL glucose levels but no incretin will be infused during this part of the test. These data will be compared when the subject repeats the GPA test with a placebo (saline or salt containing solution) infusion.",[18],"Drug: GIP",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","GLP-1","Each subject in this arm will receive GLP-1 infusion and a placebo infusion during a GPA test.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"GIP","Each subject in this arm will receive GIP infusion and placebo during a GPA test.",[15],[31],"Glucose-dependent insulinotrophic polypeptide",[33],{"name":34,"affiliation":5,"role":35},"Michael R. Rickels, MD, MS","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"Paola Alvarado","CONTACT","215-746-2081","paola.alvarado@pennmedicine.upenn.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Children's Hospital of Philadelphia and University of Pennsylvania","RECRUITING","Philadelphia","Pennsylvania","19060","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-75.16362,39.95238,{"lat":55,"lon":54},[58,59,61],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},{"name":60,"role":35,"phone":25,"phoneExt":25,"email":25},"Michael Rickels, M.D., M.S",{"name":62,"role":35,"phone":25,"phoneExt":25,"email":25},"Andrea Kelly, M.D, M.S.",{"type":35,"investigatorFullName":34,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Professor of Medicine",[66],{"name":67,"class":6},"Children's Hospital of Philadelphia","100197851","beta-cell-response-to-incretin-hormones-in-cystic-fibrosis-100197851",false,"NCT01851694","Beta-cell Response to Incretin Hormones in Cystic Fibrosis","Determination of Beta-cell Responsiveness to the Incretin Hormones GLP-1 and GIP in Cystic Fibrosis","Inclusion Criteria:\n\n1. Confirmed diagnosis of cystic fibrosis, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria,\n2. Age greater than or equal to 18y on date of consent\n3. Pancreatic insufficiency\n4. Recent OGTT consistent with Indeterminate-GT, IGT, CFRD w\u002Fo fasting hyperglycemia, or an established diagnosis of CFRD without fasting hyperglycemia\n5. For female subjects, negative urine pregnancy test at enrollment.\n\nControl Subjects:\n\n1. No history of cystic fibrosis.\n2. Age ≥ 18y on date of consent.\n3. Recent OGTT consistent with NGT.\n4. For female subjects, negative urine pregnancy test at enrollment.\n\nExclusion Criteria:\n\n1. Established diagnosis of non-CF diabetes (i.e. T1D) or CFRD with fasting hyperglycemia (fasting glucose greater than126 mg\u002FdL)\n2. History of clinically symptomatic pancreatitis within last year\n3. Prior lung or liver transplant\n4. Severe CF liver disease, as defined by portal hypertension\n5. Fundoplication-related dumping syndrome\n6. Medical co-morbidities that are not CF-related or are unstable per investigator opinion (i.e. history of bleeding disorders, immunodeficiency)\n7. Acute illness or changes in therapy (including antibiotics) within 6 weeks prior to study procedures\n8. Treatment with oral or intravenous corticosteroids within 6 weeks of study\n9. Hemoglobin less than10g\u002FdL, within 90 days of Visit 1 or at Screening\n10. Abnormal renal function, within 90 days of Visit 1 or at Screening; defined as Creatinine greater than 2x upper limit of normal (ULN) or potassium greater than 5.5mEq\u002FL on non-hemolyzed specimen\n11. Inability to perform study specific procedures (MMTT, GPA)\n12. Subjects, who in study team opinion, may be non-compliant with study procedures.\n\nControl Subjects who will be exposed to GIP only:\n\n1. History of clinically symptomatic pancreatitis.\n2. History of liver disease.\n3. 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.\n4. Hemoglobin \\\u003C10g\u002FdL, within 90 days of GPA test or at Screening.\n5. Abnormal renal function, within 90 days of GPA test or at Screening; defined as creatinine \\> 2x upper limit of normal (ULN) or potassium \\> 5.5mEq\u002FL on non-hemolyzed specimen.\n6. Inability to perform study specific procedures (MMTT, GPA).\n7. subjects, who in study team opinion, may be non-compliant with study procedures.\n8. elevation of serum amylase or lipase \\> 1.5x ULN within 90 days of GPA test.",true,"ALL","18 Years",{"count":79,"type":80},45,"ESTIMATED","INTERVENTIONAL",[83],"NA","In recent years, diabetes has emerged as one of the most significant co-diseases that many Cystic Fibrosis (CF) patients develop. Type 1 (T1D) and Type 2 (T2D) diabetes results when either the body does not make enough insulin or the body does not respond correctly to this insulin, respectively. Insulin is a hormone which is made by cells in the pancreas and helps carry glucose (sugar) from the food we eat to the cells of the body for energy. While cystic fibrosis related diabetes (CFRD) has many features similar to both T1D and T2D, patients with CF may not have the same symptoms as either T1D or T2D patients. Currently, there is little understanding of CFRD and the best options for treatment remain unclear.\n\nThe purpose of this research study is to examine and understand the various mechanisms that contribute to CFRD and gain a better understanding of potential means to treat CFRD. In particular, we plan to study the effects of incretin hormones that can enhance insulin production in CF patients.\n\nEnrollment is complete for the protocol as initially written. In order to further study the role of the incretin hormone on Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) function , we have received approval to extend our investigation to include the following study groups:\n\n* Cystic Fibrosis participants with normal glucose tolerance\n* Non-Cystic Fibrosis controls",[86,87],"Cystic Fibrosis","Pancreatic Insufficiency",[86,89,90,91,92],"Diabetes","Pancreatic insufficiency","Cystic Fibrosis with Normal Glucose Tolerance","Non-Cystic Fibrosis control group","2026-01-13",{"date":95,"type":96},"2026-01-14","ACTUAL",{"date":98,"type":25},"2013-05",{"date":100,"type":80},"2026-12",{"name":5,"class":6},1]