Effect of Lumacaftor-ivacaftor on Glucose Handling and Tolerance in Cystic Fibrosis Phe508del

• Status: Withdrawn
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to find out if the combined therapy lumacaftor-ivacaftor effects how people with cystic fibrosis respond to an oral glucose tolerance test, a test for diabetes.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Ivacaftor

Criteria

Inclusion Criteria:

1. Age 18 years old or greater

2. Patients diagnosed with CF, genotype homozygous PheDel508

3. Subject is planning on starting lumacaftor-ivacaftor for clinical reasons, with no contraindication for starting the drug* OR subject is taking combination drug and had an OGTT done at a partners facility in the 6 months prior to initiating the drug.

• Contraindications for taking drug include abnormal liver enzyme tests, renal dysfunction, pregnancy or nursing mothers

Exclusion Criteria:

1. Currently taking any medications for diabetes (including oral or injectable antihyperglycemic agents and/or insulin).

2. Had an admission for CF exacerbation less than 2 weeks prior to staring the medication. This will be defined as requiring new IV or PO antibiotics different than those used in maintenance therapy.

3. Is currently taking oral glucocorticoids or has been on oral or IV glucocorticoids in the past 2 weeks.