Clinical trial NCT05540132: Slow Digestible Carbohydrates and Exercise in Adolescents with Type 1 Diabetes
Official title: Slow-digestible Carbohydrates Consumed Prior to Exercise Improve Performance and Decrease Risk of Delayed Hypoglycemia in Adolescents with Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Hypoglycemia
Keywords: adolescent
exercise
cgm
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Within subject, randomized cross-over study
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of hypoglycemic events 12 hours after completion of exercise challenge
timeFrame: 12 hours after exercise challenge
measure: Glycemic variability during exercise challenge
timeFrame: During exercise challenge
measure: Time to completion of distance bike challenge
timeFrame: During exercise challenge
Secondary outcomes:
measure: Percent time spent in hypoglycemia following exercise challenge
timeFrame: 12 hours after exercise challenge
measure: Percent time above range, in range, and below range following exercise challenge
timeFrame: 12 hours after exercise challenge
measure: Glycemic variability in the 12 hours following the exercise test
timeFrame: 12 hours after exercise challenge
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: UB MD Pediatrics Division of Pediatric Endocrinology
state: New York
Study officials:
affiliation: State University of New York at Buffalo
name: Lucy Mastrandrea, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: