- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01072708
Determination of the Predictive Factors in the Reversibility or the Aggravation in the Disorders of the Glucose Metabolism in Cystic Fibrosis Patients (DIAMUCO)
August 27, 2025 updated by: Hospices Civils de Lyon
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
230
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Pierre-Bénite, France, 69495
- Service de Médecine Interne - Centre Hospitalier Lyon Sud
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patient with hypoglycemia treatment : insulin or oral antidiabetic
- Patient with an age < 10 years
- Patient with lung transplant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Estimate prevalence of the various stages of disorders of the glucose metabolism : glucose intolerance and diabetes
Time Frame: 3 years
|
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
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
February 19, 2010
First Submitted That Met QC Criteria
February 19, 2010
First Posted (Estimated)
February 22, 2010
Study Record Updates
Last Update Posted (Estimated)
September 4, 2025
Last Update Submitted That Met QC Criteria
August 27, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008.523/24
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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