Type 1 DiabetesNCT05540132
Slow Digestible Carbohydrates and Exercise in Adolescents With Type 1 Diabetes
A study testing maltodextrin and super starch in people with Type 1 Diabetes and Hypoglycemia, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Type 1 Diabetes, Hypoglycemia
- What is being tested?
- maltodextrin and super starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2023to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UB MD Pediatrics Division of Pediatric Endocrinology
Buffalo, New York, 14203
About this study
Official title: Slow-digestible Carbohydrates Consumed Prior to Exercise Improve Performance and Decrease Risk of Delayed Hypoglycemia in Adolescents With Type 1 Diabetes
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.
Read the 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.
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Being tested
- maltodextrin, super starch
- Keywords
- adolescent, exercise, cgm
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maltodextrinDietary supplement
Pre-exercise carbohydrate, fast-acting
super starchDietary supplement
Pre-exercise carbohydrate, slow-acting
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Dietary Supplement: super starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hypoglycemic events 12 hours after completion of exercise challenge
Review of continuous glucose monitoring data
Measured: 12 hours after exercise challenge
Glycemic variability during exercise challenge
Review of continuous glucose monitoring data
Measured: During exercise challenge
Time to completion of distance bike challenge
Number of minutes to complete 3.75 mile bike ride
Measured: During exercise challenge
Secondary outcomes (3)
Percent time spent in hypoglycemia following exercise challenge
Review of continuous glucose monitoring data
Measured: 12 hours after exercise challenge
Percent time above range, in range, and below range following exercise challenge
Review of continuous glucose monitoring data
Measured: 12 hours after exercise challenge
Glycemic variability in the 12 hours following the exercise test
Review of continuous glucose monitoring data
Measured: 12 hours after exercise challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start15 Jul 2023
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Why it stopped: Change in clinical management of patient with Type 1 diabetes, making study obsolete
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within subject, randomized cross-over study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucy D Mastrandrea, State University of New York at Buffalo
- Investigators
- Lucy Mastrandrea, MD, PhD, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540132
- Sponsor's protocol ID
- SS_T1D_2022
- Status last verified
- Feb 2026
- First submitted
- 10 Sep 2022
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slow-digestible Carbohydrates Consumed Prior to Exercise Improve Performance and Decrease Risk of Delayed Hypoglycemia in Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05540132
- Acronym / sponsor ID
- SS_T1D_2022
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Keywords
- adolescent, exercise, cgm
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in clinical management of patient with Type 1 diabetes, making study obsolete
- Enrolment
- 0 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Within subject, randomized cross-over study
| Arm | Type | Receives |
|---|---|---|
| Fast Acting Carbohydrate | Active comparator | Dietary Supplement: maltodextrinPrior to exercise performance test, subject will be randomized to consume 22 grams of fast-acting carbohydrate (maltodextrin) or slow-acting cornstarch based supplement |
| Slow-acting cornstarch supplement | Active comparator | Dietary Supplement: super starchPrior to exercise performance test, subject will be randomized to consume 22 grams of slow-acting cornstarch based supplement or fast-acting carbohydrate (maltodextrin) |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maltodextrinPre-exercise carbohydrate, fast-acting | Dietary supplement | Fast Acting Carbohydrate |
| super starchPre-exercise carbohydrate, slow-acting | Dietary supplement | Slow-acting cornstarch supplement |
Primary outcome
Number of hypoglycemic events 12 hours after completion of exercise challenge
Time frame: 12 hours after exercise challenge
Review of continuous glucose monitoring data
Glycemic variability during exercise challenge
Time frame: During exercise challenge
Review of continuous glucose monitoring data
Time to completion of distance bike challenge
Time frame: During exercise challenge
Number of minutes to complete 3.75 mile bike ride
3 secondary outcomes
Percent time spent in hypoglycemia following exercise challenge
Time frame: 12 hours after exercise challenge
Percent time above range, in range, and below range following exercise challenge
Time frame: 12 hours after exercise challenge
Glycemic variability in the 12 hours following the exercise test
Time frame: 12 hours after exercise challenge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucy Mastrandrea, MD, PhD principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maltodextrin and super starch in people with Type 1 Diabetes and Hypoglycemia, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hypoglycemic events 12 hours after completion of exercise challenge (time frame: 12 hours after exercise challenge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.