The Effect of a Pre-meal Snack and/or Exercise on Post-prandial Glycemic Excursions in Adults With Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 8 May 2023
• Main ID: NCT03710538
• Date of registration: 20/06/2018
• Prospective Registration: Yes
• Primary sponsor: Institut de Recherches Cliniques de Montreal
• Public title: The Effect of a Pre-meal Snack and/or Exercise on Post-prandial Glycemic Excursions in Adults With Cystic Fibrosis SNACK_CF
• Scientific title: The Effect of a Pre-meal Snack and/or Exercise on Post-prandial Glycemic Excursions in Adults With Cystic Fibrosis
• Date of first enrolment: April 1, 2019
• Target sample size: 14
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03710538
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

Canada

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of cystic fibrosis,

- Be over 18 years old.

Exclusion Criteria:

- Pharmacological treatment for cystic fibrosis related diabetes.

- Signs of secondary infection: the test will be practiced at least 1 month after the
end of infection treatment

- People with severe gastrointestinal illness (Crohn's disease, celiac disease and a
recent history (<1 year) of bowel obstruction).

- Allergy to one of the ingredients of the menu (example: celiac disease)

- According to the judgment of the investigator, medications or conditions that could
interfere with glucose metabolism (eg: oral steroids)

- Pregnancy in progress

- Corrector or potentiator prescribed whose dose is not stable the last 2 months.



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

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Behavioral: Exercise

Dietary Supplement: Snack beverage

Primary Outcome(s)

Total area under the curve for plasma glucose [Time Frame: Overall study period (4 hours)]

Secondary Outcome(s)

Area under the curve for plasma glucose [Time Frame: From start of study to breakfast time (1 hour)]

Area under the curve for plasma glucose [Time Frame: From time of breakfast to the end of the study (3 hours)]

Percentage of time with plasma glucose concentration above 10.0 mmol/L [Time Frame: Overall study period (4 hours)]

Area under the curve for insulin [Time Frame: From breakfast time to the end of the study (3 hours)]

Mean insulin [Time Frame: Overall study period (4 hours)]

Percentage of time with plasma glucose concentration above 11.0 mmol/L [Time Frame: Overall study period (4 hours)]

Percentage of time with plasma glucose concentration above 8.0 mmol/L [Time Frame: Overall study period (4 hours)]

Mean plasma glucose [Time Frame: Overall study period (4 hours)]

Percentage of time with plasma glucose concentration below 4.0 mmol/L [Time Frame: Overall study period (4 hours)]

Area under the curve for insulin [Time Frame: From start of study to breakfast time (1 hour)]

Total area under the curve for insulin [Time Frame: Overall study period (4 hours)]

Post-breakfast peak plasma glucose [Time Frame: 1 hour after breakfast]

Secondary ID(s)

SNACK_CF

Source(s) of Monetary Support

Please refer to primary and secondary sponsors