Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Determination of the Predictive Factors in the Reversibility or the Aggravation in the Disorders of the Glucose Metabolism in Cystic Fibrosis Patients (DIAMUCO)

This study has been completed.
Information provided by (Responsible Party):
Hospices Civils de Lyon Identifier:
First received: February 19, 2010
Last updated: March 24, 2016
Last verified: February 2016
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 Intervention
Diabetes in Cystic Fibrosis Patients
Other: Prospective cohort with an annual follow-up

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

Further study details as provided by Hospices Civils de Lyon:

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. [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 230
Study Start Date: April 2009
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01072708

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 Identifier: NCT01072708     History of Changes
Other Study ID Numbers: 2008.523/24
Study First Received: February 19, 2010
Last Updated: March 24, 2016

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

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases processed this record on May 25, 2017