One Year Glargine Treatment in CFRD Children and Adolescents

Phase 4

Completed

• Conditions: Cystic Fibrosis; Glucose Metabolism Disorders

• Registration Number: NCT00483769
• Lead Sponsor: Federico II University

Brief 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.

Study Timeline

• Study Start: 2006-02
• Study Completion: 2007-01
• Status Verified: 2007-02
• Study First Submitted: 2007-06-06
• Study First Submitted QC: 2007-06-06
• Last Update Submitted: 2007-06-06
• Study First Posted: 2007-06-07
• Last Update Posted: 2007-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients affected by Cystic Fibrosis who had shown glucose derangements.

Exclusion Criteria

• Patients with/without Cystic Fibrosis without glucose derangements.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reduction of decline in pulmonary function measured as FEV1	One year

Secondary Outcome Measures

Name	Time	Method
Improvement of: Body Mass Index, Number of Lung Infections, HbA1c	One Year

Trial Locations

Locations (1)

Deptm of Pediatrics Regional Cystic Fibrosis Center- University of Naples - Federico II; 🇮🇹 Naples, Italy