An interventional study of maltodextrin and super starch in Type 1 Diabetes and Hypoglycemia, sponsored by State University of New York at Buffalo. Withdrawn at 1 site in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Prevention
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.
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
Browse Diabetes Mellitus, Type 1 studies →State University of New York at Buffalo is the lead sponsor of 287 studies on the registry; 65 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
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Exclusion Criteria:
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
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, fast-acting
Pre-exercise carbohydrate, slow-acting
Number of hypoglycemic events 12 hours after completion of exercise challenge
Review of continuous glucose monitoring data
Time frame: 12 hours after exercise challenge
Glycemic variability during exercise challenge
Review of continuous glucose monitoring data
Time frame: During exercise challenge
Time to completion of distance bike challenge
Number of minutes to complete 3.75 mile bike ride
Time frame: During exercise challenge
Percent time spent in hypoglycemia following exercise challenge
Review of continuous glucose monitoring data
Time frame: 12 hours after exercise challenge
Percent time above range, in range, and below range following exercise challenge
Review of continuous glucose monitoring data
Time frame: 12 hours after exercise challenge
Glycemic variability in the 12 hours following the exercise test
Review of continuous glucose monitoring data
Time frame: 12 hours after exercise challenge
Plan to share: Yes — 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
Supporting information: Study protocol, Csr
No publications or documents are linked to this record.
This study is withdrawn, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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State University of New York at Buffalo