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

Not Applicable

Completed

• Conditions: Diabetes in Cystic Fibrosis Patients

• Registration Number: NCT01072708
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-02-19
• Study First Submitted QC: 2010-02-19
• Study First Posted: 2010-02-22
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-02
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	3 years

Secondary Outcome Measures

Name	Time	Method
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	3 years
Estimate prevalence of the various stages of disorders of the glucose metabolism : glucose intolerance and diabetes	3 years

Trial Locations

Locations (1)

Service de Médecine Interne - Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Bénite, France