Back to resultsOne Year Glargine Treatment in CFRD Children and Adolescents
Primary Purpose
Cystic Fibrosis, Glucose Metabolism Disorders
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Glargine
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystis Fibrosis, Glucose intolerance, Glargine, FEV1%
Eligibility Criteria
Inclusion Criteria:
- Patients affected by Cystic Fibrosis who had shown glucose derangements.
Exclusion Criteria:
- Patients with/without Cystic Fibrosis without glucose derangements.
Sites / Locations
- Deptm of Pediatrics Regional Cystic Fibrosis Center- University of Naples - Federico II
Outcomes
Primary Outcome Measures
Reduction of decline in pulmonary function measured as FEV1
Secondary Outcome Measures
Improvement of: Body Mass Index, Number of Lung Infections, HbA1c
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00483769
Brief Title
One Year Glargine Treatment in CFRD Children and Adolescents
Official Title
One-Year Glargine-Treatment Can Ameliorate Clinical Features in Cystic Fibrosis Children and Adolescents With Glucose Derangements
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federico II University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Glucose Metabolism Disorders
Keywords
Cystis Fibrosis, Glucose intolerance, Glargine, FEV1%
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Glargine
Primary Outcome Measure Information:
Title
Reduction of decline in pulmonary function measured as FEV1
Time Frame
One year
Secondary Outcome Measure Information:
Title
Improvement of: Body Mass Index, Number of Lung Infections, HbA1c
Time Frame
One Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients affected by Cystic Fibrosis who had shown glucose derangements.
Exclusion Criteria:
Patients with/without Cystic Fibrosis without glucose derangements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana Franzese, Dr
Organizational Affiliation
Federico II University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Adriana Franzese, Dr
Organizational Affiliation
University of Naples Dept of Pediatrics Regional Cystic Fibrosis Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adriana Franzese, Dr
Organizational Affiliation
Federico II University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deptm of Pediatrics Regional Cystic Fibrosis Center- University of Naples - Federico II
City
Naples
ZIP/Postal Code
80131
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
16123520
Citation
Franzese A, Spagnuolo MI, Sepe A, Valerio G, Mozzillo E, Raia V. Can glargine reduce the number of lung infections in patients with cystic fibrosis-related diabetes? Diabetes Care. 2005 Sep;28(9):2333. doi: 10.2337/diacare.28.9.2333. No abstract available.
Results Reference
result
Links:
URL
http://www.fibrosicistica.it
Description
Cystic Fibrosis center of Naples is a service of tertiary cure for patients with Cystic Fibrosis regularly attending regional Cystic Fibrosis Center
Learn more about this trial
One Year Glargine Treatment in CFRD Children and Adolescents
We'll reach out to this number within 24 hrs