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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT00476281
Date of registration: 18/05/2007
Prospective Registration: Yes
Primary sponsor: University Hospital, Strasbourg, France
Public title: Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis
Scientific 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
Date of first enrolment: April 2008
Target sample size: 114
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00476281
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Laurence KESSLER, MD
Address: 
Telephone:
Email:
Affiliation:  Hôpitaux Universitaires de Strasbourg
Key inclusion & exclusion 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



Age minimum: 10 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Diabetes
Cystic Fibrosis
Intervention(s)
Procedure: Continuous Glucose Monitoring System (CGMS)
Procedure: Urinary collect
Primary Outcome(s)
nutritional and respiratory parameters [Time Frame: five years]
Secondary Outcome(s)
abnormal glucose tolerance [Time Frame: five tears]
Secondary ID(s)
3887
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Association d'Aide aux Insuffisants Respiratoires d'Alsace Lorraine
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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