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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypoglycemia; Type 1 Diabetes
• Intervention / Treatment: Dietary supplement: maltodextrin; Dietary supplement: super starch

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • UB MD Pediatrics Division of Pediatric Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Dietary supplement: maltodextrin; Pre-exercise carbohydrate, fast-acting
Active Comparator: 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)	Dietary supplement: super starch; Pre-exercise carbohydrate, slow-acting

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: Lucy Mastrandrea, MD, PhD, State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2023
• Primary Completion (Estimated): October 15, 2025
• Study Completion (Estimated): October 15, 2025

Study Registration Dates

• First Submitted: September 10, 2022
• First Submitted That Met QC Criteria: September 10, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: exercise; adolescent; cgm
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Behavior; Nutritional and Metabolic Diseases; Hypoglycemia; Diabetes Mellitus, Type 1; Motor Activity; maltodextrin
• Other Study ID Numbers: SS_T1D_2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Consent informs subjects as follows:

If identifiers are removed from your identifiable information, that information could be used for future research studies or distributed to another investigator for future research studies without your additional informed consent. Any future use of the banked data for research outside the scope of this current protocol will be submitted as separate studies to the Institutional Review Board for review and approval, prior to conducting the research

• IPD Sharing Time Frame: Data will become available June, 2024 and will be available for 2 years
• IPD Sharing Access Criteria: Contact with Principal Investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No