Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT05540132

Slow Digestible Carbohydrates and Exercise in Adolescents With Type 1 Diabetes

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

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
State University of New York at Buffalo · Academic / Other
Sex
All
Age
12 Years – 17 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTmaltodextrinPre-exercise carbohydrate, fast-acting
DIETARY_SUPPLEMENTsuper starchPre-exercise carbohydrate, slow-acting

Timeline

Start date
2023-07-15
Primary completion
2025-10-15
Completion
2025-10-15
First posted
2022-09-14
Last updated
2026-03-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05540132. Inclusion in this directory is not an endorsement.