Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay

• Status: Unknown status
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether the anticipated use of glargine in CF patients with glucose intolerance may prevent the worsening of nutritional status and pulmonary function.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione per la ricerca sulla Fibrosi Cistica
• Treatments: Insulin; Insulin, Globin Zinc

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