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Slow Digestible Carbohydrates for Type 1 Diabetes

N/A
Waitlist Available
Led By Lucy Mastrandrea, MD, PhD
Research Sponsored by State University of New York at Buffalo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 12 - <18 year old male and female subjects with Type 1 diabetes for > 1 year
Willing to wear a continuous glucose monitor (CGM) sensor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 hours after exercise challenge
Awards & highlights

Study Summary

This trial is testing whether a corn-starch supplement can help manage blood sugar levels during exercise for adolescents with Type 1 diabetes, potentially improving their performance and glycemic variability.

Who is the study for?
Adolescents aged 12-18 with Type 1 diabetes, who can exercise and have an HbA1c level below 10.5%. They must be within a healthy weight range and willing to wear a glucose monitor. Those with severe recent hypoglycemia, chronic lung or heart conditions, food allergies, or recent diabetic ketoacidosis cannot participate.Check my eligibility
What is being tested?
The study is testing if corn-starch based supplements (maltodextrin and super starch) taken before exercise can help prevent low blood sugar afterwards, improve workout performance, and stabilize blood sugar levels during physical activity in young people with Type 1 Diabetes.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include digestive discomfort due to the carbohydrate supplements. As these are dietary substances rather than drugs, significant side effects are less likely compared to pharmaceutical interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 12 and 17 years old and have had Type 1 diabetes for over a year.
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I am willing to wear a glucose monitoring device continuously.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 hours after exercise challenge
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 hours after exercise challenge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Glycemic variability during exercise challenge
Number of hypoglycemic events 12 hours after completion of exercise challenge
Time to completion of distance bike challenge
Secondary outcome measures
Glycemic variability in the 12 hours following the exercise test
Percent time above range, in range, and below range following exercise challenge
Percent time spent in hypoglycemia following exercise challenge

Trial Design

2Treatment groups
Active Control
Group I: Fast Acting CarbohydrateActive Control1 Intervention
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 II: Slow-acting cornstarch supplementActive Control1 Intervention
Prior to exercise performance test, subject will be randomized to consume 22 grams of slow-acting cornstarch based supplement or fast-acting carbohydrate (maltodextrin)

Find a Location

Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor
244 Previous Clinical Trials
49,437 Total Patients Enrolled
Lucy Mastrandrea, MD, PhDPrincipal InvestigatorState University of New York at Buffalo

Media Library

Fast Acting Carbohydrate Clinical Trial Eligibility Overview. Trial Name: NCT05540132 — N/A
Type 1 Diabetes Research Study Groups: Fast Acting Carbohydrate, Slow-acting cornstarch supplement
Type 1 Diabetes Clinical Trial 2023: Fast Acting Carbohydrate Highlights & Side Effects. Trial Name: NCT05540132 — N/A
Fast Acting Carbohydrate 2023 Treatment Timeline for Medical Study. Trial Name: NCT05540132 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project accepting volunteers at the moment?

"Verifying the clinicaltrials.gov page, it is apparent that this experiment has ended its recruitment period which began on October 1st 2022 and concluded on September 13th 2022. However, an abundance of other medical trials are currently asking for volunteers with over 1300 studies recruiting right now."

Answered by AI

Does this research protocol permit enrollment of individuals that are over two decades old?

"This medical trial requires that its participants are between the ages of 12 and 17. As a point of comparison, there are 228 trials for minors and 954 for seniors."

Answered by AI

Could I potentially be a participant in this research endeavor?

"This research endeavor necessitates the inclusion of 20 youths aged 12 - 17 with hypoglycemia. Aspiring participants should meet a number of specifications, including: gender, Type 1 diabetes diagnosis for over one year, HbA1c below 10.5%, no sensor-augmented pump therapy usage, capability to engage in bicycle exercise and having a BMI between the tenth percentile and 95th percentiles."

Answered by AI
~9 spots leftby Oct 2024