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Trial record 37 of 747 for:    Area Under Curve AND meal

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

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ClinicalTrials.gov Identifier: NCT03710538
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Institut de Recherches Cliniques de Montreal

Brief Summary:
The investigators aim to test the feasibility and effectiveness of a pre-meal snack to reduce the postprandial glycemia (PPG) excursion after a breakfast consumption in adult patients with cystic fibrosis (CF). The investigators also want to investigate the impact of a postprandial exercise to reduce the PPG excursion. An improvement in PPG excursions can improve the condition of CF patients primarily by delaying the onset of cystic fibrosis related diabetes (CFRD) and / or by reducing the risk of lung function loss.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Dietary Supplement: Snack beverage Behavioral: Exercise Not Applicable

Detailed Description:

The investigators are proposing a randomized pilot study to explore the impact of a soy beverage of carbohydrates and protein early in the morning, to stimulate and initiate secretion of Insulin to reduce PPG excursions of the following a lunch in adult patients with CF. Investigators will also study the impact of a post meal exercise on the PPG excursion. Fourteen participants will be included and will each perform a 4-hour intervention in cross over design according to those 4 following experimental conditions:

  1. Consumption of 200ml of water (flavored) + breakfast of 90g of carbohydrates (CHO) for men and 80g for women; Sedentary activities throughout the study [condition control]
  2. Consumption of 200ml of soy beverage + 90g of carbohydrate (CHO) breakfast for men and 80g for women; Sedentary activities throughout the study [snack effect on PPG excursion]
  3. Consumption of 200ml of water (flavored) + breakfast of 90g of carbohydrates (CHO) for men and 80g for women + physical activity practice (3min walk at 60% VO2max every 30 minutes, x5); [exercise effect on the PPG excursion]
  4. Consumption of 200ml of soy beverage + breakfast of 90g of carbohydrate (CHO) breakfast for men and 80g for women + physical activity practice (3min walk at 60% VO2max every 30 minutes, x5). [Combined snack and exercise effect on the PPG excursion] Main result: plasma glucose area under the curve. The underlying mechanisms, insulin, incretin hormones (GLP-1 and GIP), acceptability and side effects (mealtime hyperglycaemia) should also be measured. At the end of this pilot project, the investigators will have established a pre-meal snack and/ or postprandial exercise have a positive impact on PPG.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
  1. Consumption of 200ml of water (flavored) + breakfast of 90g of carbohydrates (CHO) for men and 80g for women; Sedentary activities throughout the study [condition control]
  2. Consumption of 200ml of soy beverage + 90g of carbohydrate (CHO) breakfast for men and 80g for women; Sedentary activities throughout the study [snack effect on PPG excursion]
  3. Consumption of 200ml of water (flavored) + breakfast of 90g of carbohydrates (CHO) for men and 80g for women + physical activity practice (3min walk at 60% VO2max every 30 minutes, x5); [exercise effect on the PPG excursion]
  4. Consumption of 200ml of soy beverage + breakfast of 90g of carbohydrate (CHO) breakfast for men and 80g for women + physical activity practice (3min walk at 60% VO2max every 30 minutes, x5). [Combined snack and exercise effect on the PPG excursion]
Masking: Single (Participant)
Masking Description: snack beverage or flavored placebo will be not recognizable
Primary Purpose: Treatment
Official Title: The Effect of a Pre-meal Snack and/or Exercise on Post-prandial Glycemic Excursions in Adults With Cystic Fibrosis
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020


Arm Intervention/treatment
No Intervention: [Placebo + Sedentary]
1) Consumption of 200ml of water (flavored) + breakfast of 90g of carbohydrates (CHO) for men and 80g for women; Sedentary activities throughout the study
Experimental: [Snack effect + Sedentary]
2) Consumption of 200ml of soy beverage + 90g of carbohydrate (CHO) breakfast for men and 80g for women; Sedentary activities throughout the study
Dietary Supplement: Snack beverage
Consumption of a 200ml of soy beverage (100Kcal, 11g CHO, 6g proteins, 4g fat)

Experimental: [Placebo + Exercise]
3) Consumption of 200ml of water (flavored) + breakfast of 90g of carbohydrates (CHO) for men and 80g for women + physical activity practice (3min walk at 60% VO2max every 30 minutes, x5);
Behavioral: Exercise
3min walk at 60% VO2max every 30 minutes,(x5)

Experimental: [Snack + Exercise]
4) Consumption of 200ml of soy beverage + breakfast of 90g of carbohydrate (CHO) breakfast for men and 80g for women + physical activity practice (3min walk at 60% VO2max every 30 minutes, x5).
Dietary Supplement: Snack beverage
Consumption of a 200ml of soy beverage (100Kcal, 11g CHO, 6g proteins, 4g fat)

Behavioral: Exercise
3min walk at 60% VO2max every 30 minutes,(x5)




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

Secondary Outcome Measures :
  1. Area under the curve for plasma glucose [ Time Frame: From start of study to breakfast time (1 hour) ]
  2. Area under the curve for plasma glucose [ Time Frame: From time of breakfast to the end of the study (3 hours) ]
  3. Total area under the curve for insulin [ Time Frame: Overall study period (4 hours) ]
  4. Area under the curve for insulin [ Time Frame: From start of study to breakfast time (1 hour) ]
  5. Area under the curve for insulin [ Time Frame: From breakfast time to the end of the study (3 hours) ]
  6. Mean plasma glucose [ Time Frame: Overall study period (4 hours) ]
  7. Mean insulin [ Time Frame: Overall study period (4 hours) ]
  8. Percentage of time with plasma glucose concentration above 8.0 mmol/L [ Time Frame: Overall study period (4 hours) ]
  9. Percentage of time with plasma glucose concentration above 10.0 mmol/L [ Time Frame: Overall study period (4 hours) ]
  10. Percentage of time with plasma glucose concentration above 11.0 mmol/L [ Time Frame: Overall study period (4 hours) ]
  11. Percentage of time with plasma glucose concentration below 4.0 mmol/L [ Time Frame: Overall study period (4 hours) ]
  12. Post-breakfast peak plasma glucose [ Time Frame: 1 hour after breakfast ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03710538


Contacts
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Contact: Johann Colomba, PhD student 514-987-5500 ext 3320 johann.colomba@ircm.qc.ca
Contact: Virginie Messier 514-987-5500 ext 3227 virginie.messier@ircm.qc.ca

Locations
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Canada, Quebec
Institut de Recherches Cliniques de Montréal (IRCM) Recruiting
Montreal, Quebec, Canada, H2W 1R7
Sponsors and Collaborators
Institut de Recherches Cliniques de Montreal
Investigators
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Principal Investigator: Rémi Rabasa-Lhoret, MD, PhD IRCM

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Responsible Party: Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT03710538     History of Changes
Other Study ID Numbers: SNACK_CF
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut de Recherches Cliniques de Montreal:
glycemia
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases