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One Year Glargine Treatment in CFRD Children and Adolescents

NCT ID: NCT00483769

Last Updated: 2007-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cystic Fibrosis Glucose Metabolism Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Glargine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with/without Cystic Fibrosis without glucose derangements.
Minimum Eligible Age

3 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Principal Investigators

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Adriana Franzese, Dr

Role: STUDY_DIRECTOR

Federico II University

Adriana Franzese, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Naples Dept of Pediatrics Regional Cystic Fibrosis Center

Adriana Franzese, Dr

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

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

Naples, Naples, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type RESULT
PMID: 16123520 (View on PubMed)

Related Links

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http://www.fibrosicistica.it

Cystic Fibrosis center of Naples is a service of tertiary cure for patients with Cystic Fibrosis regularly attending regional Cystic Fibrosis Center

Other Identifiers

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234-234-234-234-234

Identifier Type: -

Identifier Source: org_study_id