One Year Glargine Treatment in CFRD Children and Adolescents

This study has been completed.
Sponsor:
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT00483769
First received: June 6, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: One-Year Glargine-Treatment Can Ameliorate Clinical Features in Cystic Fibrosis Children and Adolescents With Glucose Derangements

Resource links provided by NLM:


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
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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 Federico II University
Principal Investigator: Adriana Franzese, Dr University of Naples Dept of Pediatrics Regional Cystic Fibrosis Center
Principal Investigator: Adriana Franzese, Dr Federico II University
  More Information

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

Keywords provided by Federico II University:
Cystis Fibrosis
Glucose intolerance
Glargine
FEV1%

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Metabolic Diseases
Glucose Metabolism Disorders
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014