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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 (DIAMUCO)

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ClinicalTrials.gov Identifier: NCT01072708
Recruitment Status : Completed
First Posted : February 22, 2010
Last Update Posted : March 25, 2016
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Diabetes in Cystic Fibrosis Patients Other: Prospective cohort with an annual follow-up

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 Start Date : April 2009
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Other: Prospective cohort with an annual follow-up

    Annualfollow-up including :

    • oral glucose tolerance test
    • dietary survey
    • biological evaluation
    • bacteriological and respiratory measures
    • dual-energy x-ray absorptiometry
    • physical activity survey

Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. Estimate prevalence of the various stages of disorders of the glucose metabolism : glucose intolerance and diabetes [ Time Frame: 3 years ]
  2. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072708


Locations
France
Service de Médecine Interne - Centre Hospitalier Lyon Sud
Pierre Bénite, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon
More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01072708     History of Changes
Other Study ID Numbers: 2008.523/24
First Posted: February 22, 2010    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: February 2016

Keywords provided by Hospices Civils de Lyon:
Cystic fibrosis -diabetes - glucose tolerance - reversibility - oral glucose tolerance test - predictive factors

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases