Last updated on May 2018

Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-Ivacaftor

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Glucose Intolerance or Newly Diagnosis Diabetes | Cystic Fibrosis Homozygous for Phe 508 Del CFTR
  • Age: Between 12 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • patients with CF homozygous for the Phe508del CFTR mutation aged 12 years and over
  • Combined Lumacaftor-Ivacaftor treatment scheduled or already started
  • glucose intolerance in OGTT (ADA criteria) or newly diabetes diagnosed at the OGTT (ADA criteria) or diabetic patients with insulin requirement 0.3 unit / kg / day or without insulin treatment
  • signed informed consent of patient and of one parent OR legal representative for minor subject

Exclusion Criteria:

  • hypersensitivity to the active substances or to any of the excipients of Lumactfor -Ivacaftor
  • lung and/or liver transplant patient
  • Known diabetes with insulin treatment > 0.3 unit / kg / day
  • patient pregnant or wishing to pregnancy

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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