One Year Glargine Treatment in CFRD Children and Adolescents

Federico II University

Status and phase: Completed; Phase 4

Conditions: Glucose Metabolism Disorders; Cystic Fibrosis

Treatments: Drug: Glargine

Study type: Interventional

Funder types: Other

Identifiers

NCT00483769

234-234-234-234-234

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 3 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients with/without Cystic Fibrosis without glucose derangements.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)