Carbohydrate-based Strategies to Prevent Exercise-induced Hypoglycemia

NCT03214107 | Completed

• 1 other identifier: SNACK-1
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

To prevent hypoglycemia during prolonged exercise (\>30 minutes), additional carbohydrate intake is frequently required. Carbohydrate intake required will vary with insulin regimens, timing and type of exercise as well as starting blood glucose level. In addition to the amount of carbohydrate ingested, the timing of carbohydrate intake could also have an impact on glucose control during exercise. Therefore, the objective of this study will be to compare the efficacy of two snacking strategies to maintain glucose levels in the target range during an exercise period in adolescents and adults with type 1 diabetes: 1) a snack containing \~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - given 5 minutes before exercise; 2) a snack containing \~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - distributed this way: \~40% given 5 minutes before exercise, \~30% after 20 minutes of exercise and the last \~30% after 40 minutes of exercise.

Conditions

Type 1 Diabetes Mellitus

Keywords

Exercise; Hypoglycemia; Carbohydrates

Outcome Measures

Primary Outcomes (1)

• Percentage of time of capillary glucose levels spent between 4-10 mmol/L

  This time frame corresponds to the exercise period and the 1 hour following it

  This outcome will be measured over 120 minutes

Secondary Outcomes (36)

• Percentage of time of sensor glucose levels spent between 4-10 mmol/L

  This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)

• Percentage of time of glucose levels spent below 4 mmol/L

  This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)

• Decrease in glucose levels

  This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)

• Increase in glucose level

  This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)

• Number of participants with an exercise-induced hypoglycemia below 4 mmol/L

  This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)

Study Arms (2)

Full snack given before exercise

ACTIVE COMPARATOR

A snack containing \~0.5g of carbohydrates per kilogram of body weight will be given 5 minutes before exercise

Other: Exercise; Other: Snack

Distributed snack over exercise period

ACTIVE COMPARATOR

A snack containing \~0.5g of carbohydrates per kilogram of body weight distributed this way will be given: \~40% given 5 minutes before exercise, \~30% after 20 minutes of exercise and the last \~30% after 40 minutes of exercise.

Other: Exercise; Other: Snack

Interventions

Exercise OTHER

Participants will be admitted at IRCM at 14:00. At 15:30, participants will performed a 60-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). During exercise, capillary glucose levels will be measured every 10 minutes. At 16:30, the exercise will be completed and capillary glucose levels will be monitored every 20 minutes for 1 hour. At 17:30, the participant will be discharged.

Distributed snack over exercise period; Full snack given before exercise

Snack OTHER

Full snack or Distributed snack

Distributed snack over exercise period; Full snack given before exercise

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥ 14 years of old.
• Clinical diagnosis of type 1 diabetes for at least one year.
• Last (less than 3 months) HbA1c ≤ 10%.
• Patients using multiple daily injections with basal-bolus insulin regimen.

You may not qualify if:

• Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
• Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
• Abnormal blood panel and/or anemia.
• Ongoing pregnancy.
• Severe hypoglycemic episode within two weeks of screening.
• Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
• Treatment with CSII (Continuous Subcutaneous Insulin Infusion) "insulin pump therapy".

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, Canada

Location

Related Publications (1)

• Goulet-Gelinas L, Saade MB, Suppere C, Fortin A, Messier V, Taleb N, Tagougui S, Shohoudi A, Legault L, Henderson M, Rabasa-Lhoret R. Comparison of two carbohydrate intake strategies to improve glucose control during exercise in adolescents and adults with type 1 diabetes. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1238-1246. doi: 10.1016/j.numecd.2020.12.011. Epub 2020 Dec 17.

  PMID: 33632598 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity; Hypoglycemia

Interventions

Exercise; Snacks

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Meals; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Remi Rabasa-Lhoret

  Institut de recherches cliniques de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Research Platform on Obesity, Metabolism and Diabetes

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 11, 2017
• Study Start: August 3, 2017
• Primary Completion: August 2, 2019
• Study Completion: August 2, 2019
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

CA (1)