Slow Digestible Carbohydrates and Exercise in Adolescents with Type 1 Diabetes

NCT ID: NCT05540132

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-15
• Study Completion Date: 2026-06-30

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.

Conditions

Type 1 Diabetes; Hypoglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Fast Acting Carbohydrate

Prior to exercise performance test, subject will be randomized to consume 22 grams of fast-acting carbohydrate (maltodextrin) or slow-acting cornstarch based supplement

Group Type: ACTIVE_COMPARATOR

maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

Pre-exercise carbohydrate, fast-acting

Slow-acting cornstarch supplement

Prior to exercise performance test, subject will be randomized to consume 22 grams of slow-acting cornstarch based supplement or fast-acting carbohydrate (maltodextrin)

Group Type: ACTIVE_COMPARATOR

super starch

Intervention Type: DIETARY_SUPPLEMENT

Pre-exercise carbohydrate, slow-acting

Interventions

maltodextrin

Pre-exercise carbohydrate, fast-acting

Intervention Type: DIETARY_SUPPLEMENT

super starch

Pre-exercise carbohydrate, slow-acting

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Lucy D Mastrandrea

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucy Mastrandrea, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of New York at Buffalo

Locations

UB MD Pediatrics Division of Pediatric Endocrinology

Buffalo, New York, United States

Countries

United States

Other Identifiers

SS_T1D_2022

Identifier Type: -

Identifier Source: org_study_id