Diabetes in Cystic Fibrosis PatientsDIAMUCONCT01072708
Determination of the Predictive Factors in the Reversibility or the Aggravation in the Disorders of the Glucose Metabolism in Cystic Fibrosis Patients
A study testing Prospective cohort with an annual follow-up in people with Diabetes in Cystic Fibrosis Patients, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
For some years, the investigators observe an increase of the arisen of diabetes in cystic fibrosis patients However, this diabetes may be reversible. The investigators speak about " Cystic fibrosis related diabetes.". Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Diabetes in Cystic Fibrosis Patients
- What is being tested?
- Prospective cohort with an annual follow-up
- Type of treatment
- Pill or oral medicine
- How many people
- 230 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Oct 2014
- 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 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cystic fibrosis patients with at least one visit in Cystic fibrosis Center in Rhône-Alpes (France) during the second half-year 2008
- Patients with disorders or not of the glucose metabolism
- Patient with pancreatic insufficiency
Who cannot join
- Patient with hypoglycemia treatment : insulin or oral antidiabetic
- Patient with an age < 10 years
- Patient with lung transplant
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Interne - Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
About this study
Official title: Determination of the Predictive Factors in the Reversibility or the Aggravation in the Disorders of the Glucose Metabolism in Cystic Fibrosis Patients (Study DIAMUCO)
For some years, the investigators observe an increase of the arisen of diabetes in cystic fibrosis patients However, this diabetes may be reversible. The investigators speak about " Cystic fibrosis related diabetes.". The objective of this project, is to know better what facilitates the appearance and the reversibility of the diabetes, such as the genetic mutations, the respiratory state and the lung infections. Theses knowledges should allow to adapt the screening of diabetes, and its treatment, for the patients affected by cystic fibrosis.
- Conditions
- Diabetes in Cystic Fibrosis Patients
- Being tested
- Prospective cohort with an annual follow-up
- Keywords
- Cystic fibrosis -diabetes - glucose tolerance - reversibility - oral glucose tolerance test - predictive factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective cohort with an annual follow-upOther
Annualfollow-up including :
- oral glucose tolerance test
- dietary survey
- biological evaluation
- bacteriological and respiratory measures
- dual-energy x-ray absorptiometry
- physical activity survey
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the natural history of the glucose tolerance in cystic fibrosis patients and to identify the predictive factors of the reversibility or the aggravation in the disorders of the glucidic metabolism.
Measured: 3 years
Secondary outcomes (2)
Estimate prevalence of the various stages of disorders of the glucose metabolism : glucose intolerance and diabetes
Measured: 3 years
Estimate the probability of arisen the complications associated to the disorders of the glucidic metabolism : - deterioration of the respiratory function, - lung exacerbations - alteration of the nutritional state
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startApr 2009
- Primary completionOct 2014
- Study completionOct 2014
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 Diabetes in Cystic Fibrosis PatientsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072708
- Sponsor's protocol ID
- 2008.523/24
- Acronym
- DIAMUCO
- Status last verified
- Aug 2025
- First submitted
- 19 Feb 2010
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reynaud Q, Rabilloud M, Roche S, Poupon-Bourdy S, Iwaz J, Nove-Josserand R, Blond E, Laville M, Llerena C, Quetant S, Reix P, Touzet S, Durieu I. Glucose trajectories in cystic fibrosis and their association with pulmonary function. J Cyst Fibros. 2018 May;17(3):400-406. doi: 10.1016/j.jcf.2017.09.010. Epub 2017 Oct 14.
PubMed 29037538
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Predictive Factors in the Reversibility or the Aggravation in the Disorders of the Glucose Metabolism in Cystic Fibrosis Patients (Study DIAMUCO)
- ClinicalTrials.gov ID
- NCT01072708
- Acronym / sponsor ID
- DIAMUCO / 2008.523/24
- Conditions
- Diabetes in Cystic Fibrosis Patients
- Keywords
- Cystic fibrosis -diabetes - glucose tolerance - reversibility - oral glucose tolerance test - predictive factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Feb 2010 (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.
For some years, the investigators observe an increase of the arisen of diabetes in cystic fibrosis patients However, this diabetes may be reversible. The investigators speak about " Cystic fibrosis related diabetes.". The objective of this project, is to know better what facilitates the appearance and the reversibility of the diabetes, such as the genetic mutations, the respiratory state and the lung infections. Theses knowledges should allow to adapt the screening of diabetes, and its treatment, for the patients affected by cystic fibrosis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Cystic fibrosis patients with at least one visit in Cystic fibrosis Center in Rhône-Alpes (France) during the second half-year 2008
- Patients with disorders or not of the glucose metabolism
- Patient with pancreatic insufficiency
Key exclusion criteria (3 listed)
- Patient with hypoglycemia treatment : insulin or oral antidiabetic
- Patient with an age < 10 years
- Patient with lung transplant
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 |
|---|---|---|
| Prospective cohort with an annual follow-upAnnualfollow-up including : * oral glucose tolerance test * dietary survey * biological evaluation * bacteriological and respiratory measures * dual-energy x-ray absorptiometry * physical activity survey | Other | – |
Primary outcome
Describe the natural history of the glucose tolerance in cystic fibrosis patients and to identify the predictive factors of the reversibility or the aggravation in the disorders of the glucidic metabolism.
Time frame: 3 years
2 secondary outcomes
Estimate prevalence of the various stages of disorders of the glucose metabolism : glucose intolerance and diabetes
Time frame: 3 years
Estimate the probability of arisen the complications associated to the disorders of the glucidic metabolism : - deterioration of the respiratory function, - lung exacerbations - alteration of the nutritional state
Time frame: 3 years
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 4 Sep 2025.
- Results publication: PubMed 29037538Reynaud Q, Rabilloud M, Roche S, Poupon-Bourdy S, Iwaz J, Nove-Josserand R, Blond E, Laville M, Llerena C, Quetant S, Reix P, Touzet S, Durieu I. Glucose trajectories in cystic fibrosis and their association with pulmonary function. J Cyst Fibros. 2018 May;17(3):400-406. doi: 10.1016/j.jcf.2017.09.010. Epub 2017 Oct 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prospective cohort with an annual follow-up in people with Diabetes in Cystic Fibrosis Patients, run by Hospices Civils de Lyon at 1 site 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 3 inclusion and 3 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 4 Sep 2025. 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 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?
Describe the natural history of the glucose tolerance in cystic fibrosis patients and to identify the predictive factors of the reversibility or the aggravation in the disorders of the glucidic metabolism. (time frame: 3 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 NCT01072708, 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 4 Sep 2025.