Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis

• 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
• 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

Cystic Fibrosis

Diabetes

Intervention(s)

Procedure: Urinary collect

Procedure: Continuous Glucose Monitoring System (CGMS)

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