Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476281
• Other study ID #: 3887
• Status: Completed
• Phase: N/A
• Start date: April 2008
• Est. completion date: January 2020

Study information

• Verified date: March 2020
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Diabetes
• Fibrosis

Intervention

Procedure:
• Urinary collect

• Continuous Glucose Monitoring System (CGMS)

Locations

Country	Name	City	State
France	Centre Robert Debré - CHU Angers	Angers
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	CRCM Centre de Perharidy	Roscoff
France	Service d'Endocrinologie, Diabète et Maladies Métaboliques - Hôpital Civil	Strasbourg
France	Service de Pédiatrie II	Strasbourg
France	Service de Pneumologie - Hôpital de Hautepierre	Strasbourg
France	Service de Réanimation Médicale - Hôpital Civil	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France	Association d'Aide aux Insuffisants Respiratoires d'Alsace Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nutritional and respiratory parameters	descriptive comparison of nutritional and respiratory parameters in function abnormalities glucose tolerance.	five years
Secondary	abnormal glucose tolerance	assess the prevalence of abnormal glucose tolerance.	five tears