Slow-acting cornstarch supplement for Hypoglycemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UB MD Pediatrics Division of Pediatric Endocrinology, Buffalo, NY
Hypoglycemia+3 More
maltodextrin - DietarySupplement
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Type 1 Diabetes Mellitus
  • Hypoglycemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 3 Secondary · Reporting Duration: 12 hours after exercise challenge

Hour 12
Glycemic variability in the 12 hours following the exercise test
Number of hypoglycemic events 12 hours after completion of exercise challenge
Percent time above range, in range, and below range following exercise challenge
Percent time spent in hypoglycemia following exercise challenge
During exercise challenge
Glycemic variability during exercise challenge
Time to completion of distance bike challenge

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Slow-acting cornstarch supplement
1 of 2
Fast Acting Carbohydrate
1 of 2
Active Control

20 Total Participants · 2 Treatment Groups

Primary Treatment: Slow-acting cornstarch supplement · No Placebo Group · N/A

Slow-acting cornstarch supplement
DietarySupplement
ActiveComparator Group · 1 Intervention: super starch · Intervention Types: DietarySupplement
Fast Acting Carbohydrate
DietarySupplement
ActiveComparator Group · 1 Intervention: maltodextrin · Intervention Types: DietarySupplement

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 hours after exercise challenge
Closest Location: UB MD Pediatrics Division of Pediatric Endocrinology · Buffalo, NY
Photo of new york 1Photo of new york 2Photo of new york 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Hypoglycemia
0 CompletedClinical Trials

Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor
208 Previous Clinical Trials
44,220 Total Patients Enrolled
Lucy Mastrandrea, MD, PhDPrincipal InvestigatorState University of New York at Buffalo

Eligibility Criteria

Age < 18 · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Your body mass index is greater than 10% or less than 95% of the normal range.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.