Back to resultsDetermination of the Predictive Factors in the Reversibility or the Aggravation in the Disorders of the Glucose Metabolism in Cystic Fibrosis Patients (DIAMUCO)
Primary Purpose
Diabetes in Cystic Fibrosis Patients
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Prospective cohort with an annual follow-up
Sponsored by
About this trial
This is an interventional other trial for Diabetes in Cystic Fibrosis Patients focused on measuring Cystic fibrosis -diabetes - glucose tolerance - reversibility - oral glucose tolerance test - predictive factors
Eligibility Criteria
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
Sites / Locations
- Service de Médecine Interne - Centre Hospitalier Lyon Sud
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Estimate prevalence of the various stages of disorders of the glucose metabolism : glucose intolerance and diabetes
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
Full Information
NCT ID
NCT01072708
First Posted
February 19, 2010
Last Updated
May 23, 2019
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT01072708
Brief Title
Determination of the Predictive Factors in the Reversibility or the Aggravation in the Disorders of the Glucose Metabolism in Cystic Fibrosis Patients
Acronym
DIAMUCO
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.". 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes in Cystic Fibrosis Patients
Keywords
Cystic fibrosis -diabetes - glucose tolerance - reversibility - oral glucose tolerance test - predictive factors
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Prospective cohort with an annual follow-up
Intervention Description
Annualfollow-up including :
oral glucose tolerance test
dietary survey
biological evaluation
bacteriological and respiratory measures
dual-energy x-ray absorptiometry
physical activity survey
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Estimate prevalence of the various stages of disorders of the glucose metabolism : glucose intolerance and diabetes
Time Frame
3 years
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Service de Médecine Interne - Centre Hospitalier Lyon Sud
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
29037538
Citation
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.
Results Reference
result
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Determination of the Predictive Factors in the Reversibility or the Aggravation in the Disorders of the Glucose Metabolism in Cystic Fibrosis Patients
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