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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Hospices Civils de Lyon.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01072708
First received: February 19, 2010
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Estimate prevalence of the various stages of disorders of the glucose metabolism : glucose intolerance and diabetes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: April 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (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
  Eligibility

Ages Eligible for Study:   10 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01072708

Contacts
Contact: DURIEU Isabelle 0478869049 ext +33 isabelle.durieu@chu-lyon.fr

Locations
France
Service de Médecine Interne - Centre Hospitalier Lyon Sud Recruiting
Pierre Bénite, France, 69495
Contact: DURIEU Isabelle    0478861352 ext +33    isabelle.durieu@chu-lyon.fr   
Principal Investigator: DURIEU Isabelle         
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Pr Isabelle DURIEU, Hospices Civils de Lyon - Service de Médecine Interne - Centre Hospitalier Lyon-Sud
ClinicalTrials.gov Identifier: NCT01072708     History of Changes
Other Study ID Numbers: 2008.523/24
Study First Received: February 19, 2010
Last Updated: February 19, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Diabetes Mellitus
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014