NCT00483769

One Year Glargine Treatment in CFRD Children and Adolescents

One-Year Glargine-Treatment Can Ameliorate Clinical Features in Cystic Fibrosis Children and Adolescents With Glucose Derangements

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 3 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

Glargine treatment can improve the clinical features in Cystic Fibrosis patients affected by glucose derangements

Detailed description

To evaluate the effect of glargine treatment on BMI, lung function, acute pulmonary infections and HbA1c in cystic fibrosis (CF) patients with different glucose derangements, eighty-seven patients were screened for glucose derangements with fasting hyperglycaemia or abnormalities at the oral glucose tolerance test. They were classified on the basis of a "gluco-score" ranging 0-5. Patients with gluco-score \> 1 were treated with glargine. We report on the results of the first 20 patients who completed 12 months of treatment. BMI z-score, forced expiratory volume in the first second (FEV1), number of acute lung infections in the previous year and HbA1c were the study outcomes.

Conditions

• Cystic Fibrosis
• Glucose Metabolism Disorders

Interventions

Type	Name	Description
DRUG	Glargine

Timeline

• Start date: 2006-02-01
• Completion: 2007-01-01
• First posted: 2007-06-07
• Last updated: 2007-06-07

Locations

1 site across 1 country: Italy