Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis

Study Overview
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Brief Summary
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Diabetes is a important complication of cystic fibrosis (CF). The improved life expectancy of patients with cystic fibrosis, as a result of advances in medical therapy, has resulted in an increasing prevalence of cystic fibrosis-related diabetes (CFRD). CFRD is associated with accelerated pulmonary decline and increased mortality. Pulmonary effects are seen some years before the diagnosis of CFRD implying that impaired glucose tolerance may be very early detrimental. Insulin treatment is clearly indicated in patients with CFRD to control symptoms and reduce complications. However, at the state of impaired glucose tolerance or fasting hyperglycaemia, current screening methods are not suitable for the early management of hyperglycaemia.The recent introduction of the continuous glucose monitoring system (CGMS), which provides a continuous glucose profile, has revealed to be clinically relevant in the investigation of glucose excursions over a long period. This device, widely use in diabetic non cystic fibrosis patients, has been validated in non diabetic cystic fibrosis subjects. Previous studies of continuous glucose monitoring have been realized in CF patients with normal glucose tolerance and diabetes and compared with non CF controlThe aim of our study is to evaluate the glucose profile with continuous glucose monitoring the nutritional and respiratory status in cystic fibrosis subjects, according to their glucose tolerance.

Official Title
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Multicenter Prospective Study of Abnormalies Tolerance Glucose by the Continuous Measurement of Glucose of Nutritional Status and Breathing in the Patient With Cystic Fibrosis

Conditions
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Cystic Fibrosis, Diabetes

Intervention / Treatment
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* Procedure: Urinary collect
* Procedure: Continuous Glucose Monitoring System (CGMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients 10 years and older with cystic fibrosis not known diabetics with fasting blood glucose <1.26 g / l outside periods of exacerbation and / or glucocorticoid therapy affiliated to a social security scheme having received the results of the mandatory medical examination having signed an informed consent Exclusion Criteria: Patient transplanted lung and / or liver Subject during participation in an interventional clinical trial unable to give informed about the information patient under judicial protection patient under tutorship or curatorship pregnancy breastfeeding patient treated with the combination lumacaftor and ivacaftor

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: abnormal glucose tolerance<br>abnormal glucose tolerance | Procedure: Urinary collect<br> <br> Procedure: Continuous Glucose Monitoring System (CGMS)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nutritional and respiratory parameters | descriptive comparison of nutritional and respiratory parameters in function abnormalities glucose tolerance. | five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abnormal glucose tolerance | assess the prevalence of abnormal glucose tolerance. | five tears |