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Completed

NCT Number: NCT00483769

One Year Glargine Treatment in CFRD Children and Adolescents

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

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Infant, Newborn, Diseases Lung Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

3 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Naples, 80131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with/without Cystic Fibrosis without glucose derangements.

Treatment and study plan

Glargine

Drug

Primary outcomes

  1. Reduction of decline in pulmonary function measured as FEV1

    Time frame: One year

Secondary outcomes

  1. Improvement of: Body Mass Index, Number of Lung Infections, HbA1c

    Time frame: One Year

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

One-Year Glargine-Treatment Can Ameliorate Clinical Features in Cystic Fibrosis Children and Adolescents With Glucose Derangements

Important dates

Study start
2006
Study completion
2007
First posted
Jun 7, 2007
Registry last updated
Jun 7, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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