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One Year Glargine Treatment in CFRD Children and Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00483769
Recruitment Status : Completed
First Posted : June 7, 2007
Last Update Posted : June 7, 2007
Sponsor:
Information provided by:
Federico II University

Study Description
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Brief Summary:
Glargine treatment can improve the clinical features in Cystic Fibrosis patients affected by glucose derangements

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Glucose Metabolism Disorders Drug: Glargine Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: One-Year Glargine-Treatment Can Ameliorate Clinical Features in Cystic Fibrosis Children and Adolescents With Glucose Derangements
Study Start Date : February 2006
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Reduction of decline in pulmonary function measured as FEV1 [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Improvement of: Body Mass Index, Number of Lung Infections, HbA1c [ Time Frame: One Year ]

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483769


Locations
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Italy
Deptm of Pediatrics Regional Cystic Fibrosis Center- University of Naples - Federico II
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
Investigators
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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
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Additional 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

Publications of Results:

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ClinicalTrials.gov Identifier: NCT00483769    
Other Study ID Numbers: 234-234-234-234-234
First Posted: June 7, 2007    Key Record Dates
Last Update Posted: June 7, 2007
Last Verified: February 2007
Keywords provided by Federico II University:
Cystis Fibrosis
Glucose intolerance
Glargine
FEV1%
Additional relevant MeSH terms:
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Cystic Fibrosis
Metabolic Diseases
Glucose Metabolism Disorders
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs