Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT00476281 |
Date of registration:
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18/05/2007 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis
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Scientific title:
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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:
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April 2008 |
Target sample size:
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114 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT00476281 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Laurence KESSLER, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Hôpitaux Universitaires de Strasbourg |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Diabetes
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Cystic Fibrosis
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Intervention(s)
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Procedure: Continuous Glucose Monitoring System (CGMS)
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Procedure: Urinary collect
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Primary Outcome(s)
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nutritional and respiratory parameters
[Time Frame: five years]
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Secondary Outcome(s)
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abnormal glucose tolerance
[Time Frame: five tears]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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