One Year Glargine Treatment in CFRD Children and Adolescents - Full Text View

Sponsored by:	Federico II University
Information provided by:	Federico II University
ClinicalTrials.gov Identifier:	NCT00483769

Purpose

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

Condition	Intervention	Phase
Cystic Fibrosis Glucose Metabolism Disorders	Drug: Glargine	Phase IV

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis Metabolic Disorders

Drug Information available for: Insulin glargine Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	One-Year Glargine-Treatment Can Ameliorate Clinical Features in Cystic Fibrosis Children and Adolescents With Glucose Derangements

Further study details as provided by Federico II University:

Primary Outcome Measures:

Reduction of decline in pulmonary function measured as FEV1 [ Time Frame: One year ]

Secondary Outcome Measures:

Improvement of: Body Mass Index, Number of Lung Infections, HbA1c [ Time Frame: One Year ]

Enrollment:	20
Study Start Date:	February 2006
Study Completion Date:	January 2007

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.

Eligibility

Ages Eligible for Study:	3 Years to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients affected by Cystic Fibrosis who had shown glucose derangements.

Exclusion Criteria:

Patients with/without Cystic Fibrosis without glucose derangements.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483769

Locations

Italy
Deptm of Pediatrics Regional Cystic Fibrosis Center- University of Naples - Federico II
Naples, Italy, 80131

Sponsors and Collaborators

Federico II University

Investigators

Study Director:	Adriana Franzese, Dr	University of Naples - Federico II
Principal Investigator:	Adriana Franzese, Dr	University of Naples Dept of Pediatrics Regional Cystic Fibrosis Center
Principal Investigator:	Adriana Franzese, Dr	University of Naples Federico II

More Information

Cystic Fibrosis center of Naples is a service of tertiary cure for patients with Cystic Fibrosis regularly attending regional Cystic Fibrosis Center This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications of Results:

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. No abstract available.

Study ID Numbers:	234-234-234-234-234
Study First Received:	June 6, 2007
Last Updated:	June 6, 2007
ClinicalTrials.gov Identifier:	NCT00483769
Health Authority:	Italy: Ministry of Health

Keywords provided by Federico II University:

Cystis Fibrosis
Glucose intolerance
Glargine
FEV1%

Study placed in the following topic categories:

Metabolic Diseases
Fibrosis
Glucose Intolerance
Digestive System Diseases
Cystic Fibrosis
Respiratory Tract Diseases
Genetic Diseases, Inborn

Lung Diseases
Glargine
Pancreatic Diseases
Infant, Newborn, Diseases
Glucose Metabolism Disorders
Metabolic disorder
Cystic fibrosis

Additional relevant MeSH terms:

Hypoglycemic Agents
Pathologic Processes
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009