Slow Digestible Carbohydrates and Exercise in Adolescents With Type 1 Diabetes

Study Overview
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Brief Summary
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In this within-subject cross-over study, the investigators hypothesize that corn-starch based supplements taken prior to exercise will decrease the risk of delayed hypoglycemia in adolescents with T1D, improve performance during exercise, and decrease glycemic variability during exercise.

Detailed Description
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Type 1 diabetes (T1D), one of the most common chronic diseases in adolescents, is caused by the destruction of insulin producing beta cells which are located in the pancreas. There are many factors that impact diabetes control which are insulin administration, intake of food and exercise. When an individual exercises, weight is better managed which allows for a better cardiovascular system. Exercising also improves insulin sensitivity which can increased the risk for delayed hypoglycemia (low blood sugar). Many individuals with T1D do not participate (or under-participate) in exercise due to the fear of hypoglycemia. This study will recruit adolescents with Type 1 diabetes to undergo a maximal exercise test to determine their VO2max. Study participants then will complete 2 exercise performance tests prior to which the participant will be randomized to consume 22 grams of either fast acting carbohydrates or long-acting cornstarch based supplements. Subjects will be asked to bike for 45 minutes (at 50% of VO2max) and then complete a 3.75 mile bike ride as quickly as possible. The investigators will document the time to completion of the bike ride as well as monitor glucose levels via continuous glucose monitoring for 12 hours after completion of the exercise test.

Official Title
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Slow-digestible Carbohydrates Consumed Prior to Exercise Improve Performance and Decrease Risk of Delayed Hypoglycemia in Adolescents With Type 1 Diabetes

Conditions
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Type 1 Diabetes, Hypoglycemia

Intervention / Treatment
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* Dietary Supplement: maltodextrin
* Dietary Supplement: super starch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 12 - <18 year old male and female subjects with Type 1 diabetes for > 1 year HbA1c <10.5% Body Mass Index >10th % and <95th% Not being treated with sensor-augmented pump therapy Ability to participate in exercise activity - biking Willing to wear a continuous glucose monitor (CGM) sensor Exclusion Criteria: Severe hypoglycemia (requiring glucagon or external assistance) in last 6 months Admission for diabetic ketoacidosis in last 3 months History of chronic lung disease, congenital heart disease or chronic asthma Food (including corn)/dye allergies Other chronic medical conditions except for well-controlled thyroid disease

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Within subject, randomized cross-over study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fast Acting Carbohydrate<br>Prior to exercise performance test, subject will be randomized to consume 22 grams of fast-acting carbohydrate (maltodextrin) or slow-acting cornstarch based supplement | Dietary Supplement: maltodextrin<br>* Pre-exercise carbohydrate, fast-acting<br>|
| Active Comparator: Slow-acting cornstarch supplement<br>Prior to exercise performance test, subject will be randomized to consume 22 grams of slow-acting cornstarch based supplement or fast-acting carbohydrate (maltodextrin) | Dietary Supplement: super starch<br>* Pre-exercise carbohydrate, slow-acting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hypoglycemic events 12 hours after completion of exercise challenge | Review of continuous glucose monitoring data | 12 hours after exercise challenge | 
| Glycemic variability during exercise challenge | Review of continuous glucose monitoring data | During exercise challenge | 
| Time to completion of distance bike challenge | Number of minutes to complete 3.75 mile bike ride | During exercise challenge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent time spent in hypoglycemia following exercise challenge | Review of continuous glucose monitoring data | 12 hours after exercise challenge | 
| Percent time above range, in range, and below range following exercise challenge | Review of continuous glucose monitoring data | 12 hours after exercise challenge | 
| Glycemic variability in the 12 hours following the exercise test | Review of continuous glucose monitoring data | 12 hours after exercise challenge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescent, exercise, cgm