Slow Digestible Carbohydrates and Exercise in Adolescents With Type 1 Diabetes

Not Applicable

Active, not recruiting

• Conditions: Type 1 Diabetes; Hypoglycemia
• Interventions: Dietary Supplement: super starch; Dietary Supplement: maltodextrin

• Registration Number: NCT05540132
• Lead Sponsor: State University of New York at Buffalo

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-09-10
• Study First Submitted QC: 2022-09-10
• Study First Posted: 2022-09-14
• Study Start: 2023-07-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-03
• Primary Completion: 2024-10
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Slow-acting cornstarch supplement	super starch	Prior to exercise performance test, subject will be randomized to consume 22 grams of slow-acting cornstarch based supplement or fast-acting carbohydrate (maltodextrin)
Fast Acting Carbohydrate	maltodextrin	Prior to exercise performance test, subject will be randomized to consume 22 grams of fast-acting carbohydrate (maltodextrin) or slow-acting cornstarch based supplement

Primary Outcome Measures

Name	Time	Method
Glycemic variability during exercise challenge	During exercise challenge	Review of continuous glucose monitoring data
Time to completion of distance bike challenge	During exercise challenge	Number of minutes to complete 3.75 mile bike ride
Number of hypoglycemic events 12 hours after completion of exercise challenge	12 hours after exercise challenge	Review of continuous glucose monitoring data

Secondary Outcome Measures

Name	Time	Method
Percent time spent in hypoglycemia following exercise challenge	12 hours after exercise challenge	Review of continuous glucose monitoring data
Percent time above range, in range, and below range following exercise challenge	12 hours after exercise challenge	Review of continuous glucose monitoring data
Glycemic variability in the 12 hours following the exercise test	12 hours after exercise challenge	Review of continuous glucose monitoring data

Trial Locations

Locations (1)

UB MD Pediatrics Division of Pediatric Endocrinology; 🇺🇸 Buffalo, New York, United States