Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis
- Conditions
- Cystic FibrosisDiabetes
- Interventions
- Procedure: Urinary collectProcedure: Continuous Glucose Monitoring System (CGMS)
- Registration Number
- NCT00476281
- Lead Sponsor
- University Hospital, Strasbourg, France
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description abnormal glucose tolerance Continuous Glucose Monitoring System (CGMS) abnormal glucose tolerance abnormal glucose tolerance Urinary collect abnormal glucose tolerance
- Primary Outcome Measures
Name Time Method nutritional and respiratory parameters five years descriptive comparison of nutritional and respiratory parameters in function abnormalities glucose tolerance.
- Secondary Outcome Measures
Name Time Method abnormal glucose tolerance five tears assess the prevalence of abnormal glucose tolerance.
Trial Locations
- Locations (9)
Service de Pneumologie - Hôpital de Hautepierre
🇫🇷Strasbourg, France
Service de Réanimation Médicale - Hôpital Civil
🇫🇷Strasbourg, France
Service d'Endocrinologie et Métabolisme - CHRU de Lille
🇫🇷Lille, France
Hôpital Laennec - CHU de Nantes
🇫🇷Nantes, France
Service de Pédiatrie A - CHU de Reims
🇫🇷Reims, France
Service de Pédiatrie II
🇫🇷Strasbourg, France
Centre Robert Debré - CHU Angers
🇫🇷Angers, France
CRCM Centre de Perharidy
🇫🇷Roscoff, France
Service d'Endocrinologie, Diabète et Maladies Métaboliques - Hôpital Civil
🇫🇷Strasbourg, France