Carbohydrate-based Strategies to Prevent Exercise-induced Hypoglycemia

NCT ID: NCT03214107

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-03
• Study Completion Date: 2019-08-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Full snack given before exercise

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

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: 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.

Snack

Intervention Type: OTHER

Full snack or Distributed snack

Distributed snack over exercise period

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.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: 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.

Snack

Intervention Type: OTHER

Full snack or Distributed snack

Interventions

Exercise

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.

Intervention Type: OTHER

Snack

Full snack or Distributed snack

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Males and females ≥ 14 years of old.

2. Clinical diagnosis of type 1 diabetes for at least one year.

3. Last (less than 3 months) HbA1c ≤ 10%.

4. Patients using multiple daily injections with basal-bolus insulin regimen.

Exclusion Criteria

1. 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.

2. Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.

3. Abnormal blood panel and/or anemia.

4. Ongoing pregnancy.

5. Severe hypoglycemic episode within two weeks of screening.

6. 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).

7. Treatment with CSII (Continuous Subcutaneous Insulin Infusion) "insulin pump therapy".

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Recherches Cliniques de Montreal

OTHER

Sponsor Role: lead

Responsible Party

Rémi Rabasa-Lhoret

Director of the Research Platform on Obesity, Metabolism and Diabetes

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Remi Rabasa-Lhoret

Role: PRINCIPAL_INVESTIGATOR

Institut de recherches cliniques de Montréal

Locations

Institut de recherches cliniques de Montréal

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 33632598 (View on PubMed)

Other Identifiers

SNACK-1

Identifier Type: -

Identifier Source: org_study_id