Status:
COMPLETED
The Effect of Soluble Fiber to Reduce Post-prandial Glycemic Excursion in Adults With Cystic Fibrosis
Lead Sponsor:
Institut de Recherches Cliniques de Montreal
Collaborating Sponsors:
Canadian Cystic Fibrosis Foundation
Université de Montréal
Conditions:
Cystic Fibrosis-related Diabetes
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
With improved survival, the clinical spectrum of cystic fibrosis (CF), a complex multi systemic disease, continue to evolve. A major emerging complication is CF related diabetes (CFRD) which is occurr...
Detailed Description
With improved survival, the clinical spectrum of cystic fibrosis (CF), a complex multi systemic disease, continue to evolve. A major emerging complication is CF related diabetes (CFRD). CFRD is a majo...
Eligibility Criteria
Inclusion
- Diagnosed with CF
- Aged above 18 years
- CF-Impaired glucose tolerance, CF-indeterminate glucose tolerance (INDET), de-novo diabetes not requiring immediate treatment and diabetes without pharmacological treatment, based on the oral glucose tolerance test (OGTT) performed within three months of the first visit
Exclusion
- Treated or longstanding CFRD
- Subjects taking medication or affected by conditions that could interfere with glucose metabolism in the last 6 weeks: hemoptysis, fever, IV antibiotic treatment, pregnancy and oral steroids. If a patient presents any sign of infection confirmed by a trained CF pneumologist, OGTT testing is postponed to the next medical appointment 1 months later.
- Subjects with severe gastrointestinal disease (Crohn disease, coeliac disease and recent (\<1 year) history of intestinal occlusion).
- Subjects with intestinal obstruction history.
- Allergy to an ingredient in the menu.
- Corrector or potentiator prescribed within the last 6 months prior to the first visit.
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT02810691
Start Date
July 1 2016
End Date
April 1 2018
Last Update
July 17 2018
Active Locations (1)
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1
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada, H2W 1R7