Slow Digestible Carbohydrates and Exercise in Adolescents With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05540132
• Other study ID #: SS_T1D_2022
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 15, 2023
• Est. completion date: June 2025

Study information

• Verified date: August 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes

Intervention

Dietary Supplement:
• maltodextrin
Pre-exercise carbohydrate, fast-acting
• super starch
Pre-exercise carbohydrate, slow-acting

Locations

Country	Name	City	State
United States	UB MD Pediatrics Division of Pediatric Endocrinology	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hypoglycemic events 12 hours after completion of exercise challenge	Review of continuous glucose monitoring data	12 hours after exercise challenge
Primary	Glycemic variability during exercise challenge	Review of continuous glucose monitoring data	During exercise challenge
Primary	Time to completion of distance bike challenge	Number of minutes to complete 3.75 mile bike ride	During exercise challenge
Secondary	Percent time spent in hypoglycemia following exercise challenge	Review of continuous glucose monitoring data	12 hours after exercise challenge
Secondary	Percent time above range, in range, and below range following exercise challenge	Review of continuous glucose monitoring data	12 hours after exercise challenge
Secondary	Glycemic variability in the 12 hours following the exercise test	Review of continuous glucose monitoring data	12 hours after exercise challenge