Ivacaftor (Kalydeco) and Insulin in Cystic Fibrosis (CF)

Completed

Conditions studied: Cystic Fibrosis Related Diabetes, Cystic Fibrosis

In brief

This study is aimed at better understanding the impact of ivacaftor upon insulin and incretin secretion and glucose tolerance in patients with Cystic Fibrosis with a glycine (G551D) mutation. Investigators hypothesize that treatment with ivacaftor improves insulin secretion in individuals with CF.

Key facts

Study ID

NCT02039986

Run by

Children's Hospital of Philadelphia

People needed

13

Starts

2014-01-06

Expected to finish

2016-10-11

Last updated by the study team

2018-12-14

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 6 yrs or older with cystic fibrosis
• at least one G551D CFTR mutation or other non-G551D gating mutation, or residual function CFTR mutation such as, but not limited to, R117H mutation, for which ivacaftor is to be initiated.
• Plan to initiate ivacaftor treatment for FDA approved indications by clinical care team or as part of an ongoing study of ivacaftor for other CFTR mutations, including gating mutations, or residual function mutations.
• not pregnant

You may not qualify if…

• established diagnosis of non-CF related diabetes (ie., Type I diabetes)
• history of clinically symptomatic pancreatitis in past year
• prior lung or liver transplant
• severe CF liver disease
• fundoplication-related dumping syndrome
• medical co-morbidities that are not CF-related or are unstable per the Investigator opinion
• acute CF pulmonary exacerbation within 4 weeks prior to study procedures
• treatment with oral or intravenous corticosteroids within 4 weeks of study
• hemoglobin <10g/dL within 90 days of GPA test or at Screening
• abnormal renal function within 90 days of GPA test or at Screening
• long-standing CFRD with fasting hyperglycemia, elevated HbA1C (>8) beyond time surrounding diagnosis of CFRD, significant basal insulin requirement
• inability to perform study specific procedures (MMTT, GPA).

Where it is running

• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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