NCT Number: NCT00476281
Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis
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.
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Notify MeKey information
Conditions
Age range
10 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Centre Robert Debré - CHU Angers, Angers, France
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Continuous Glucose Monitoring System (CGMS)
ProcedurePrimary outcomes
-
nutritional and respiratory parameters
Time frame: five years
descriptive comparison of nutritional and respiratory parameters in function abnormalities glucose tolerance.
Secondary outcomes
-
abnormal glucose tolerance
Time frame: five tears
assess the prevalence of abnormal glucose tolerance.
Sponsors and collaborators
Lead sponsor
University Hospital, Strasbourg, France
Other
Collaborators
- Association d'Aide aux Insuffisants Respiratoires d'Alsace Lorraine
Registry information
Official study 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
Important dates
- Study start
- 2008
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- May 21, 2007
- Registry last updated
- Apr 28, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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