Cystic FibrosisNCT00476281
Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis
A study testing Urinary collect and Continuous Glucose Monitoring System (CGMS) in people with Cystic Fibrosis and Diabetes, run by University Hospital, Strasbourg, France at 9 sites in France.
Trial summary
Diabetes is a important complication of cystic fibrosis (CF). The improved life expectancy of patients with cystic fibrosis, as a result of advances in medical therapy, has resulted in an increasing prevalence of cystic fibrosis-related diabetes (CFRD). Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Cystic Fibrosis, Diabetes
- What is being tested?
- Urinary collect and Continuous Glucose Monitoring System (CGMS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 9 sitesFrance
- Study dates
- Apr 2008to Jan 2020
- Phase
- Interventional
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients 10 years and older with cystic fibrosis
- not known diabetics with fasting blood glucose <1.26 g / l
- outside periods of exacerbation and / or glucocorticoid therapy
- affiliated to a social security scheme
- having received the results of the mandatory medical examination
- having signed an informed consent
Who cannot join
- Patient transplanted lung and / or liver
- Subject during participation in an interventional clinical trial
- unable to give informed about the information
- patient under judicial protection
- patient under tutorship or curatorship
- pregnancy
- breastfeeding
- patient treated with the combination lumacaftor and ivacaftor
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Centre Robert Debré - CHU Angers
Angers
Service d'Endocrinologie et Métabolisme - CHRU de Lille
Lille, 59037
Hôpital Laennec - CHU de Nantes
Nantes
Service de Pédiatrie A - CHU de Reims
Reims
CRCM Centre de Perharidy
Roscoff, 29684
Service d'Endocrinologie, Diabète et Maladies Métaboliques - Hôpital Civil
Strasbourg, 67091
Service de Réanimation Médicale - Hôpital Civil
Strasbourg, 67091
Service de Pneumologie - Hôpital de Hautepierre
Strasbourg, 67098
Service de Pédiatrie II
Strasbourg, 67098
About this study
Official title: Multicenter Prospective Study of Abnormalies Tolerance Glucose by the Continuous Measurement of Glucose of Nutritional Status and Breathing in the Patient With Cystic Fibrosis
Diabetes is a important complication of cystic fibrosis (CF). The improved life expectancy of patients with cystic fibrosis, as a result of advances in medical therapy, has resulted in an increasing prevalence of cystic fibrosis-related diabetes (CFRD). CFRD is associated with accelerated pulmonary decline and increased mortality. Pulmonary effects are seen some years before the diagnosis of CFRD implying that impaired glucose tolerance may be very early detrimental. Insulin treatment is clearly indicated in patients with CFRD to control symptoms and reduce complications. However, at the state of impaired glucose tolerance or fasting hyperglycaemia, current screening methods are not suitable for the early management of hyperglycaemia.The recent introduction of the continuous glucose monitoring system (CGMS), which provides a continuous glucose profile, has revealed to be clinically relevant in the investigation of glucose excursions over a long period. This device, widely use in diabetic non cystic fibrosis patients, has been validated in non diabetic cystic fibrosis subjects. Previous studies of continuous glucose monitoring have been realized in CF patients with normal glucose tolerance and diabetes and compared with non CF controlThe aim of our study is to evaluate the glucose profile with continuous glucose monitoring the nutritional and respiratory status in cystic fibrosis subjects, according to their glucose tolerance.
- Conditions
- Cystic Fibrosis, Diabetes
- Being tested
- Urinary collect, Continuous Glucose Monitoring System (CGMS)
- Medical subject headings
- Cystic Fibrosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary collectProcedure or surgery
Continuous Glucose Monitoring System (CGMS)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| abnormal glucose tolerance | Other | abnormal glucose tolerance Receives: Procedure: Urinary collect; Procedure: Continuous Glucose Monitoring System (CGMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
nutritional and respiratory parameters
descriptive comparison of nutritional and respiratory parameters in function abnormalities glucose tolerance.
Measured: five years
Secondary outcomes (1)
abnormal glucose tolerance
assess the prevalence of abnormal glucose tolerance.
Measured: five tears
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startApr 2008
- Primary completionJan 2020
- Study completionJan 2020
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 University Hospital, Strasbourg, FranceThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- Association d'Aide aux Insuffisants Respiratoires d'Alsace Lorraine
- Responsible party
- Sponsor
- Investigators
- Laurence KESSLER, MD, Study director, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476281
- Sponsor's protocol ID
- 3887
- Status last verified
- Mar 2020
- First submitted
- 18 May 2007
- Last updated
- 28 Apr 2020
- Results posted
- No
Publications
Leclercq A, Gauthier B, Rosner V, Weiss L, Moreau F, Constantinescu AA, Kessler R, Kessler L. Early assessment of glucose abnormalities during continuous glucose monitoring associated with lung function impairment in cystic fibrosis patients. J Cyst Fibros. 2014 Jul;13(4):478-84. doi: 10.1016/j.jcf.2013.11.005. Epub 2013 Dec 17.
PubMed 24359972
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Study of Abnormalies Tolerance Glucose by the Continuous Measurement of Glucose of Nutritional Status and Breathing in the Patient With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00476281
- Acronym / sponsor ID
- 3887
- Conditions
- Cystic Fibrosis, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- Association d'Aide aux Insuffisants Respiratoires d'Alsace Lorraine
- Study start
- Apr 2008
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 21 May 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.
Diabetes is a important complication of cystic fibrosis (CF). The improved life expectancy of patients with cystic fibrosis, as a result of advances in medical therapy, has resulted in an increasing prevalence of cystic fibrosis-related diabetes (CFRD). CFRD is associated with accelerated pulmonary decline and increased mortality. Pulmonary effects are seen some years before the diagnosis of CFRD implying that impaired glucose tolerance may be very early detrimental. Insulin treatment is clearly indicated in patients with CFRD to control symptoms and reduce complications. However, at the state of impaired glucose tolerance or fasting hyperglycaemia, current screening methods are not suitable for the early management of hyperglycaemia.The recent introduction of the continuous glucose monitoring system (CGMS), which provides a continuous glucose profile, has revealed to be clinically relevant in the investigation of glucose excursions over a long period. This device, widely use in diabetic non cystic fibrosis patients, has been validated in non diabetic cystic fibrosis subjects. Previous studies of continuous glucose monitoring have been realized in CF patients with normal glucose tolerance and diabetes and compared with non CF controlThe aim of our study is to evaluate the glucose profile with continuous glucose monitoring the nutritional and respiratory status in cystic fibrosis subjects, according to their glucose tolerance.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| abnormal glucose tolerance | Other | Procedure: Urinary collect, Procedure: Continuous Glucose Monitoring System (CGMS)abnormal glucose tolerance |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- patients 10 years and older with cystic fibrosis
- not known diabetics with fasting blood glucose <1.26 g / l
- outside periods of exacerbation and / or glucocorticoid therapy
- affiliated to a social security scheme
- having received the results of the mandatory medical examination
Key exclusion criteria (8 listed)
- Patient transplanted lung and / or liver
- Subject during participation in an interventional clinical trial
- unable to give informed about the information
- patient under judicial protection
- patient under tutorship or curatorship
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 |
|---|---|---|
| Urinary collect | Procedure or surgery | abnormal glucose tolerance |
| Continuous Glucose Monitoring System (CGMS) | Procedure or surgery | abnormal glucose tolerance |
Primary outcome
nutritional and respiratory parameters
Time frame: five years
descriptive comparison of nutritional and respiratory parameters in function abnormalities glucose tolerance.
1 secondary outcome
abnormal glucose tolerance
Time frame: five tears
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 28 Apr 2020.
- Derived from this study: PubMed 24359972Leclercq A, Gauthier B, Rosner V, Weiss L, Moreau F, Constantinescu AA, Kessler R, Kessler L. Early assessment of glucose abnormalities during continuous glucose monitoring associated with lung function impairment in cystic fibrosis patients. J Cyst Fibros. 2014 Jul;13(4):478-84. doi: 10.1016/j.jcf.2013.11.005. Epub 2013 Dec 17.
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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.
Laurence KESSLER, MD study director
Hôpitaux Universitaires de Strasbourg
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urinary collect and Continuous Glucose Monitoring System (CGMS) in people with Cystic Fibrosis and Diabetes, run by University Hospital, Strasbourg, France at 9 sites in France.
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 6 inclusion and 8 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 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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.
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?
nutritional and respiratory parameters (time frame: five years). 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 NCT00476281, 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 28 Apr 2020.