The Effect of Combination Lumacaftor and Ivacaftor on Markers of Hyperglycemia
Status
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Details and patient eligibility
About
The purpose of this research study is to find out if the combined therapy lumacaftor-ivacaftor affects glycemia in patient with cystic fibrosis.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
- Age 18 years old or greater
- Patients diagnosed with cystic fibrosis (CF), genotype homozygous Phe508del
- Subject has been started on lumacaftor-ivacaftor for clinical reasons, with no contraindication for starting the drug* * Contraindications for taking drug include abnormal liver enzyme tests, renal dysfunction, pregnancy or nursing mothers
Exclusion Criteria
- Does not have a HgbA1c within 1 year prior to starting medication.
- Has not been on the combination therapy for at least 2 months
Trial design
Primary purpose
Allocation
Interventional model
Masking
1 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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