NCT05540132

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

July 15, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

2.3 years

First QC Date

September 10, 2022

Last Update Submit

February 26, 2026

Conditions

Type 1 DiabetesHypoglycemia

Keywords

adolescentexercisecgm

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Percent time spent in hypoglycemia following exercise challenge

    12 hours after exercise challenge

  • Percent time above range, in range, and below range following exercise challenge

    12 hours after exercise challenge

  • Glycemic variability in the 12 hours following the exercise test

    12 hours after exercise challenge

Study Arms (2)

Fast Acting Carbohydrate

ACTIVE COMPARATOR

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

Slow-acting cornstarch supplement

ACTIVE COMPARATOR

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

Interventions

maltodextrinDIETARY_SUPPLEMENT

Pre-exercise carbohydrate, fast-acting

Fast Acting Carbohydrate
super starchDIETARY_SUPPLEMENT

Pre-exercise carbohydrate, slow-acting

Slow-acting cornstarch supplement

Eligibility Criteria

Age12 Years - 17 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll genders are eligible, patients self-identification of gender will be recorded
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UB MD Pediatrics Division of Pediatric Endocrinology

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1HypoglycemiaMotor Activity

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Lucy Mastrandrea, MD, PhD

    State University of New York at Buffalo

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Within subject, randomized cross-over study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 10, 2022

First Posted

September 14, 2022

Study Start

July 15, 2023

Primary Completion

October 15, 2025

Study Completion

October 15, 2025

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Data will become available June, 2024 and will be available for 2 years
Access Criteria
Contact with Principal Investigator

Locations

US(1)