The purpose of this research study is to find out if the combined therapy lumacaftor-ivacaftor affects glycemia in patient with cystic fibrosis.
This is a single center, open label study. Patients will have 1 visits at the Diabetes Research Center (DRC), or Clinical Research Center (CRC). The participants will have been previously screened to make sure they are candidates for the study. These patients will be contacted prior to their first visit to discuss enrollment in the study. At the study visit the participant will come to the CRC or DRC for a research visit. The following will occur at this study visit: informed consent; brief medical history; weight and height; vital signs and blood pressure; blood draw for DNA extraction, A1c and an extra research tube for storage. This will be scheduled at a time that is convenient to the patient.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
1
Drug given for cystic fibrosis
Change in glycated hemoglobin (hemoglobin A1C)
A blood test will be used to determine the hemoglobin A1c change while on the medication.
Time frame: 1 year
Change in units of insulin used over a period of 6 months to 1 year.
Using chart review, the change in insulin units used per day will be calculated
Time frame: 1 year
Change in glycemia contingent on genetic risk score
The investigators will examine how change in glycemia is dependent on genotype at variants associated with type 2 diabetes and insulin secretion using genetic risk scores.
Time frame: 1 year
Pulmonary function test (PFT) forced expiratory volume at one second (FEV1) measurements
The investigators will compare how PFT measurement of FEV1 are related to changes in glycemia
Time frame: 1 year
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