The Effect of Soluble Fiber to Reduce Post-prandial Glycemic Excursion in Adults With Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02810691
• Date of registration: 14/06/2016
• Prospective Registration: Yes
• Primary sponsor: Institut de Recherches Cliniques de Montreal
• Public title: The Effect of Soluble Fiber to Reduce Post-prandial Glycemic Excursion in Adults With Cystic Fibrosis SOFI
• Scientific title: The Effect of Soluble Fiber to Reduce Post-prandial Glycemic Excursion in Adults With Cystic Fibrosis
• Date of first enrolment: July 2016
• Target sample size: 14
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02810691
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Rémi Rabasa-Lhoret, MD,PhD
• Affiliation: IRCM

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis-related Diabetes

Cystic Fibrosis

Intervention(s)

Dietary Supplement: Placebo (for fiber supplementation)

Dietary Supplement: Soluble fiber supplementation

Primary Outcome(s)

Plasma glucose area under the curve [Time Frame: 3 hours]

Secondary Outcome(s)

Mean plasma glucose [Time Frame: 9 hours (over study period)]

Positive incremental area under the curve for post-prandial glucose and insulin excursions [Time Frame: 3 hours]

Incretin hormones [Time Frame: Each 30 minutes, up to 510 minutes, from 8h30 am to 5h00 pm]

Percentage of time with plasma glucose concentration a. >8.0 mmol/L, b. >10.0 mmol/L, c. >11.0 mmol/L, and d. <4.0 mmol/L [Time Frame: 9 hours (over study period)]

Post-meal peak plasma glucose [Time Frame: 3 hours after each meal]

Plasma insulin area under the curve [Time Frame: 3 hours]

Side effects of the supplement [Time Frame: 60, 180, 300, 420 and 540 minutes after the beginning of the test]

Secondary ID(s)

SOFI

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Université de Montréal

Canadian Cystic Fibrosis Foundation