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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

Be younger than 18 years old

Must not have

History of chronic lung disease, congenital heart disease or chronic asthma

Other chronic medical conditions except for well-controlled thyroid disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 hours after exercise challenge

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of chronic lung or heart disease, or asthma.

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I have no chronic conditions except for well-managed thyroid disease.

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I have had a severe low blood sugar episode needing help in the last 6 months.

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I was hospitalized for diabetic ketoacidosis within the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 hours after exercise challenge

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Glycemic variability during exercise challenge

Number of hypoglycemic events 12 hours after completion of exercise challenge

Time to completion of distance bike challenge

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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)

0 / 5Eligibility criteria met