Cystic FibrosisPhase 4NCT00483769
One Year Glargine Treatment in CFRD Children and Adolescents
A Phase 4 study testing Glargine in people with Cystic Fibrosis and Glucose Metabolism Disorders, run by Federico II University at 1 site in Italy.
Trial summary
Glargine treatment can improve the clinical features in Cystic Fibrosis patients affected by glucose derangements Read more about this study
- Who is it for?
- Ages 3 to 20 years
- Conditions the study is for
- Cystic Fibrosis, Glucose Metabolism Disorders
- What is being tested?
- Glargine
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2006to Jan 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients affected by Cystic Fibrosis who had shown glucose derangements.
Who cannot join
- Patients with/without Cystic Fibrosis without glucose derangements.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Deptm of Pediatrics Regional Cystic Fibrosis Center- University of Naples - Federico II
Naples, Naples, 80131
About this study
Official title: One-Year Glargine-Treatment Can Ameliorate Clinical Features in Cystic Fibrosis Children and Adolescents With Glucose Derangements
Glargine treatment can improve the clinical features in Cystic Fibrosis patients affected by glucose derangements
Read the 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.
- Conditions
- Cystic Fibrosis, Glucose Metabolism Disorders
- Being tested
- Glargine
- Keywords
- Cystis Fibrosis, Glucose intolerance, Glargine, FEV1%
- Medical subject headings
- Cystic Fibrosis, Glucose Metabolism Disorders, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlargineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of decline in pulmonary function measured as FEV1
Measured: One year
Secondary outcomes (1)
Improvement of: Body Mass Index, Number of Lung Infections, HbA1c
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2007 (estimated)
- Study startFeb 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Investigators
- Adriana Franzese, Dr, Study director, Federico II UniversityAdriana Franzese, Dr, Principal investigator, University of Naples Dept of Pediatrics Regional Cystic Fibrosis CenterAdriana Franzese, Dr, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483769
- Sponsor's protocol ID
- 234-234-234-234-234
- Status last verified
- Feb 2007
- First submitted
- 6 Jun 2007
- Last updated
- 7 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16123520
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-Year Glargine-Treatment Can Ameliorate Clinical Features in Cystic Fibrosis Children and Adolescents With Glucose Derangements
- ClinicalTrials.gov ID
- NCT00483769
- Acronym / sponsor ID
- 234-234-234-234-234
- Conditions
- Cystic Fibrosis, Glucose Metabolism Disorders
- Keywords
- Cystis Fibrosis, Glucose intolerance, Glargine, FEV1%
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Jan 2007 (actual)
- First posted
- 7 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients affected by Cystic Fibrosis who had shown glucose derangements.
Key exclusion criteria (1 listed)
- Patients with/without Cystic Fibrosis without glucose derangements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glargine | Drug | – |
Primary outcome
Reduction of decline in pulmonary function measured as FEV1
Time frame: One year
1 secondary outcome
Improvement of: Body Mass Index, Number of Lung Infections, HbA1c
Time frame: One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2007.
- Results publication: PubMed 16123520Franzese 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.
- Cystic Fibrosis center of Naples is a service of tertiary cure for patients with Cystic Fibrosis regularly attending regional Cystic Fibrosis CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana Franzese, Dr study director
Federico II University
Adriana Franzese, Dr principal investigator
University of Naples Dept of Pediatrics Regional Cystic Fibrosis Center
Adriana Franzese, Dr principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glargine in people with Cystic Fibrosis and Glucose Metabolism Disorders, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of decline in pulmonary function measured as FEV1 (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00483769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2007.