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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00483769
Enrollment
20
Registered
2007-06-07
Start date
2006-02-28
Completion date
2007-01-31
Last updated
2007-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis, Glucose Metabolism Disorders

Keywords

Cystis Fibrosis, Glucose intolerance, Glargine, FEV1%

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.

Interventions

DRUGGlargine

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 20 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Patients with/without Cystic Fibrosis without glucose derangements.

Design outcomes

Primary

MeasureTime frame
Reduction of decline in pulmonary function measured as FEV1One year

Secondary

MeasureTime frame
Improvement of: Body Mass Index, Number of Lung Infections, HbA1cOne Year

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026