[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100197909":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":19,"interventions":25,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":68,"collaborators":70,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":13,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":13,"enrollmentInfo":82,"targetDuration":13,"studyType":85,"phases":13,"briefSummary":86,"conditions":87,"keywords":13,"overallStatus":44,"whyStopped":13,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Children's Hospital of Philadelphia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Blood sample for DNA to genotype TCF7L2 and about 10 other GWAS-implicated T2DM genes.","To examine the prevalence of GWAS-implicated T2DM alleles (including TCF7L2) across the spectrum of glucose abnormalities in children and adults with CF.","1 day",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","CFRD is associated with worse nutritional status, greater pulmonary function decline, and increased mortality, highlighting its relevance in CF and arises primarily from compromised insulin secretion--traditionally considered a by-product of pancreatic exocrine tissue damage and fibrosis. Recent developments in the field of diabetes are propelling a re-examination of this basic explanation. Genome-wide association studies have associated genetic variants in TCF7L2, a transcription factor implicated in enteroendocrine function, with increased susceptibility to T2DM and CFRD.\n\nThe Objectives of this study are to perform targeted sequencing of TCF7L2 and other GWAS-associated T2DM genes in the pediatric and adult CF populations and then to compare insulin secretory capacity, β-cell sensitivity to glucose, and incretin secretion in non-diabetic CF subjects with high and low-risk alleles.\n\nPhase 1 will include 450-500 subjects (Children age\\>= 2 years, adolescents, and adults) for TCF7L2 genotype and ten other GWAS-implicated T2DM genes. The distribution of TCF7L2 and other GWAS-implicated T2 DM genes across the spectrum of glucose abnormalities will be described. Phase 1 requires a single blood or saliva sample and review of medical records.","Patients with Cystic Fibrosis age \\>2 yrs",[20],{"label":21,"type":13,"description":22,"interventionNames":23},"Patients with Cystic Fibrosis","Blood or saliva sample collection and medical record review.",[24],"Genetic: Blood or Saliva Sample Collection",[26],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":13},"GENETIC","Blood or Saliva Sample Collection","A blood or saliva sample will be obtained for genotyping of TCF7L2 and approximately ten other genes implicated in type 2 diabetes.",[21],[32],{"name":33,"affiliation":5,"role":34},"Andrea Kelly, MD","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":13,"email":40},"Rachel Walega","CONTACT","267-586-5969","walegar1@chop.edu",[42,59],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"The Children's Hopsital of Philadelphia","RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-75.16362,39.95238,{"lat":54,"lon":53},[57,58],{"name":37,"role":38,"phone":39,"phoneExt":13,"email":40},{"name":33,"role":34,"phone":13,"phoneExt":13,"email":13},{"facility":60,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"The University of Pennsylvania",{"type":51,"coordinates":62},[53,54],{"lat":54,"lon":53},[65,66],{"name":37,"role":38,"phone":39,"phoneExt":13,"email":40},{"name":67,"role":34,"phone":13,"phoneExt":13,"email":13},"Michael Rickels, MD",{"type":69,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR",[71],{"name":72,"class":6},"University of Pennsylvania","100197909","genetics-of-insulin-and-incretins-in-cystic-fibrosis-100197909",false,"NCT01852448","Genetics of Insulin and Incretins in Cystic Fibrosis","Evaluation of the Enteroinsular Axis in Cystic Fibrosis","Inclusion Criteria\n\n1. Subjects age \\>2y\n2. Diagnosis of Cystic Fibrosis\n3. For subjects\\\u003C 18 years, parental\u002Fguardian permission (informed consent) and if appropriate, child assent\n\nExclusion Criteria 1. Established diagnosis of non-CFRD (cystic fibrosis related diabetes) (e.g T1DM)\n\n.","ALL","2 Years",{"count":83,"type":84},550,"ESTIMATED","OBSERVATIONAL","Cystic fibrosis related diabetes (CFRD) is associated with worse CF-relevant outcomes.\n\nThe mechanisms underlying CFRD development are not fully understood, but recent evidence suggests Type 2 Diabetes Mellitus (T2DM) mechanisms may be involved and may involve incretins (gut secreted hormones that augment insulin secretion in response to a nutrient load).\n\nThis study will examine the prevalence of Genome wide association study (GWAS)-implicated T2DM alleles (including TCF7L2) across the spectrum of glucose abnormalities in CF and will use this information to compare incretin and insulin secretion in non-diabetic children and adults with high risk and low risk alleles.",[88],"Cystic Fibrosis","2026-09-15",{"date":91,"type":92},"2026-09-16","ACTUAL",{"date":94,"type":13},"2013-05",{"date":96,"type":84},"2027-07",{"name":5,"class":6},2]