The Effect of Combination Lumacaftor and Ivacaftor on Markers of Hyperglycemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2018-05-01

Brief Summary

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The purpose of this research study is to find out if the combined therapy lumacaftor-ivacaftor affects glycemia in patient with cystic fibrosis.

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Detailed Description

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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.

Conditions

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Cystic Fibrosis Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Lumacaftor-ivacaftor

Subjects will be monitored for glycemic changes before and after starting lumacaftor-ivacaftor.

Group Type EXPERIMENTAL

lumacaftor-ivacaftor

Intervention Type DRUG

Drug given for cystic fibrosis

Interventions

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lumacaftor-ivacaftor

Drug given for cystic fibrosis

Intervention Type DRUG

Other Intervention Names

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Orkambi

Eligibility Criteria

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Inclusion Criteria

1. Age 18 years old or greater
2. Patients diagnosed with cystic fibrosis (CF), genotype homozygous Phe508del
3. 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