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

August 27, 2025 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Diabetes in Cystic Fibrosis Patients

Intervention / Treatment

Other: Prospective cohort with an annual follow-up

Study Type

Interventional

Enrollment (Actual)

230

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Pierre-Bénite, France, 69495
    - Service de Médecine Interne - Centre Hospitalier Lyon Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Other
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Estimate prevalence of the various stages of disorders of the glucose metabolism : glucose intolerance and diabetes Time Frame: 3 years	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	3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 May;17(3):400-406. doi: 10.1016/j.jcf.2017.09.010. Epub 2017 Oct 14.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

February 19, 2010

First Submitted That Met QC Criteria