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

Diabetes in Cystic Fibrosis Patients Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072708
• Other study ID #: 2008.523/24
• Status: Completed
• Phase: N/A
• Start date: April 2009
• Est. completion date: October 2014

Study information

• Verified date: February 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Diabetes in Cystic Fibrosis Patients
• Fibrosis

Intervention

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

Locations

Country	Name	City	State
France	Service de Médecine Interne - Centre Hospitalier Lyon Sud	Pierre Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

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 Ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Estimate prevalence of the various stages of disorders of the glucose metabolism : glucose intolerance and diabetes		3 years
Secondary	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