Ivacaftor (Kalydeco) and Insulin in Cystic Fibrosis (CF)
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|ClinicalTrials.gov Identifier: NCT02039986|
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : December 14, 2018
|Condition or disease|
|Cystic Fibrosis Related Diabetes Cystic Fibrosis|
|Study Type :||Observational|
|Actual Enrollment :||13 participants|
|Official Title:||Effects of Ivacaftor (Kalydeco) Treatment Upon Insulin and Incretin Secretion in Patients With Cystic Fibrosis|
|Actual Study Start Date :||January 6, 2014|
|Actual Primary Completion Date :||October 11, 2016|
|Actual Study Completion Date :||October 11, 2016|
all subjects enrolled in same cohort
- Change from baseline in insulin secretion capacity at 16 weeks [ Time Frame: baseline and 16 weeks ]To compare insulin secretion and maximal insulin secretory capacity prior to initiation of ivacaftor and after 16 weeks of ivacaftor treatment in subjects with CF and at least one G551D CFTR mutation, or other CFTR gating mutation, and to explore the impact of ivacaftor upon incretin secretion, incretin regulation of insulin secretion, and glucose excursion during a mixed meal tolerance test in CF.
- Composite change from baseline in relationships of insulin secretion and protein and interleukin levels at 16 weeks [ Time Frame: baseline and 16 weeks ]To explore the composite relationships of insulin secretion, maximal insulin secretory capacity, and incretin secretion with secreted frizzled protein-4 levels and interleukin 1β levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039986
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Andrea Kelly, MD, MSCE||Children's Hospital of Philadelphia|