Clinical trial NCT00476281: Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis
Official title: Multicenter Prospective Study of Abnormalies Tolerance Glucose by the Continuous Measurement of Glucose of Nutritional Status and Breathing in the Patient With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Diabetes
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
Collaborators: name: Association d'Aide aux Insuffisants Respiratoires d'Alsace Lorraine
First posted: 2007-05-21
Enrollment: 114
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: nutritional and respiratory parameters
timeFrame: five years
Secondary outcomes:
measure: abnormal glucose tolerance
timeFrame: five tears
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Robert Debré - CHU Angers
city: Lille
country: France
facility: Service d'Endocrinologie et Métabolisme - CHRU de Lille
city: Nantes
country: France
facility: Hôpital Laennec - CHU de Nantes
city: Reims
country: France
facility: Service de Pédiatrie A - CHU de Reims
city: Roscoff
country: France
facility: CRCM Centre de Perharidy
city: Strasbourg
country: France
facility: Service d'Endocrinologie, Diabète et Maladies Métaboliques - Hôpital Civil
city: Strasbourg
country: France
facility: Service de Réanimation Médicale - Hôpital Civil
city: Strasbourg
country: France
facility: Service de Pneumologie - Hôpital de Hautepierre
city: Strasbourg
country: France
facility: Service de Pédiatrie II
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Laurence KESSLER, MD
role: STUDY_DIRECTOR
References:
citation: Leclercq A, Gauthier B, Rosner V, Weiss L, Moreau F, Constantinescu AA, Kessler R, Kessler L. Early assessment of glucose abnormalities during continuous glucose monitoring associated with lung function impairment in cystic fibrosis patients. J Cyst Fibros. 2014 Jul;13(4):478-84. doi: 10.1016/j.jcf.2013.11.005. Epub 2013 Dec 17.