Slow Digestible Carbohydrates and Exercise in Adolescents With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes, Hypoglycemia
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
maltodextrin
super starch
Sponsored by
About this trial
This is an interventional prevention trial for Type 1 Diabetes focused on measuring adolescent, exercise, cgm
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
Sites / Locations
- UB MD Pediatrics Division of Pediatric Endocrinology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Fast Acting Carbohydrate
Slow-acting cornstarch supplement
Arm Description
Prior to exercise performance test, subject will be randomized to consume 22 grams of fast-acting carbohydrate (maltodextrin) or slow-acting cornstarch based supplement
Prior to exercise performance test, subject will be randomized to consume 22 grams of slow-acting cornstarch based supplement or fast-acting carbohydrate (maltodextrin)
Outcomes
Primary Outcome Measures
Number of hypoglycemic events 12 hours after completion of exercise challenge
Review of continuous glucose monitoring data
Glycemic variability during exercise challenge
Review of continuous glucose monitoring data
Time to completion of distance bike challenge
Number of minutes to complete 3.75 mile bike ride
Secondary Outcome Measures
Percent time spent in hypoglycemia following exercise challenge
Review of continuous glucose monitoring data
Percent time above range, in range, and below range following exercise challenge
Review of continuous glucose monitoring data
Glycemic variability in the 12 hours following the exercise test
Review of continuous glucose monitoring data
Full Information
NCT ID
NCT05540132
First Posted
September 10, 2022
Last Updated
August 1, 2023
Sponsor
State University of New York at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT05540132
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 15, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Hypoglycemia
Keywords
adolescent, exercise, cgm
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Within subject, randomized cross-over study
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fast Acting Carbohydrate
Arm Type
Active Comparator
Arm Description
Prior to exercise performance test, subject will be randomized to consume 22 grams of fast-acting carbohydrate (maltodextrin) or slow-acting cornstarch based supplement
Arm Title
Slow-acting cornstarch supplement
Arm Type
Active Comparator
Arm Description
Prior to exercise performance test, subject will be randomized to consume 22 grams of slow-acting cornstarch based supplement or fast-acting carbohydrate (maltodextrin)
Intervention Type
Dietary Supplement
Intervention Name(s)
maltodextrin
Intervention Description
Pre-exercise carbohydrate, fast-acting
Intervention Type
Dietary Supplement
Intervention Name(s)
super starch
Intervention Description
Pre-exercise carbohydrate, slow-acting
Primary Outcome Measure Information:
Title
Number of hypoglycemic events 12 hours after completion of exercise challenge
Description
Review of continuous glucose monitoring data
Time Frame
12 hours after exercise challenge
Title
Glycemic variability during exercise challenge
Description
Review of continuous glucose monitoring data
Time Frame
During exercise challenge
Title
Time to completion of distance bike challenge
Description
Number of minutes to complete 3.75 mile bike ride
Time Frame
During exercise challenge
Secondary Outcome Measure Information:
Title
Percent time spent in hypoglycemia following exercise challenge
Description
Review of continuous glucose monitoring data
Time Frame
12 hours after exercise challenge
Title
Percent time above range, in range, and below range following exercise challenge
Description
Review of continuous glucose monitoring data
Time Frame
12 hours after exercise challenge
Title
Glycemic variability in the 12 hours following the exercise test
Description
Review of continuous glucose monitoring data
Time Frame
12 hours after exercise challenge
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
All genders are eligible, patients self-identification of gender will be recorded
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucy Mastrandrea, MD, PhD
Organizational Affiliation
State University of New York at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
UB MD Pediatrics Division of Pediatric Endocrinology
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
Data will become available June, 2024 and will be available for 2 years
IPD Sharing Access Criteria
Contact with Principal Investigator
Learn more about this trial
Slow Digestible Carbohydrates and Exercise in Adolescents With Type 1 Diabetes
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