One Year Glargine Treatment in CFRD Children and Adolescents | NCT00483769

Studies
One Year Glargine Treatment in CFRD Children and Adolescents

NCT00483769

Sponsor

Federico II University

Status

Completed

Last Update Posted

Jun 7, 2007Estimated

Enrollment

20Actual

Phase

Phase 4

Conditions

Cystic Fibrosis
Glucose Metabolism Disorders

Interventions

Glargine

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Not provided

Completion Date

Jan 2007Actual

First Submitted Date

Jun 6, 2007

First Submission Date that Met QC Criteria

Jun 6, 2007

First Posted Date

Jun 7, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2007

Last Update Posted Date

Jun 7, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Name	Type	Description	Arm Group Labels	Other Names
Glargine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of decline in pulmonary function measured as FEV1		One year

Secondary Outcomes

Measure	Description	Time Frame
Improvement of: Body Mass Index, Number of Lung Infections, HbA1c		One Year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients affected by Cystic Fibrosis who had shown glucose derangements.

Exclusion Criteria:

Patients with/without Cystic Fibrosis without glucose derangements.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adriana Franzese, Dr	Federico II University	Study Director
Adriana Franzese, Dr	University of Naples Dept of Pediatrics Regional Cystic Fibrosis Center	Principal Investigator
Adriana Franzese, Dr	Federico II University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Deptm of Pediatrics Regional Cystic Fibrosis Center- University of Naples - Federico II		Naples	Naples	80131	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16123520	Result	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.

ID	Term
D003550	Cystic Fibrosis
D044882	Glucose Metabolism Disorders
D018149	Glucose Intolerance

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones