Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT00687466
Eligibility Criteria:
Inclusion Criteria:
* Ascertained diagnosis of CF
* Age ≥ 10 years
* Glucide intolerance: 2 pathologic OGTT ( at 120' glucose value: \>140 mg% and \<200 mg%) at 2-6 months' interval between each other
* At least one of the following conditions:
* BMI (body mass index) \< 10th centile for age and sex (according to Rolland Cachera 1991)
* Loss of one BMI centile class for age and sex in the last year (according to Rolland Cachera 1991)
* FEV1 ≤ 80% of predicted
* FEV1 decrease ≥ 10% in the last year
Exclusion Criteria:
* Specific contraindications for the use of glargine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
70 Years
Study:
NCT00687466
Study Brief:
Protocol Section:
NCT00687466