Type 1 DiabetesEXCITE-1NCT05561517
Competition Induced Hyperglycemia in Athletes With Type 1 Diabetes
A study testing 5 K running in people with Type 1 Diabetes and Hyperglycemia Stress, run by University of Aarhus at 1 site in Denmark.
Trial summary
Design and methods 12 athletes with T1D and 12 healthy athletes are included in a prospective experimental randomized, cross-over study. Athletes are provided with a Dexcom G6 CGM to measure glucose excursions before, during and after exercise and a Holter ECG-E-patch to measure HRV. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Hyperglycemia Stress
- What is being tested?
- 5 K running
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2023to 1 Sep 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- T1D and healthy athletes who are otherwise healthy
- Age between 18 and 65 years
- HbA1c less than 70 mmol/mol
- The athletes must be engaged in competitive sports that includes running, and agree to participate in a local 5 km running competition within 3 months
Who cannot join
- Proliferative retinopathy
- Hypoglycemia unawareness
- Heart disease and other conditions which may be negatively affected by the VO2 max test and study days
Trial locations and contacts
1 site in 1 country.
About this study
Design and methods 12 athletes with T1D and 12 healthy athletes are included in a prospective experimental randomized, cross-over study. Athletes are provided with a Dexcom G6 CGM to measure glucose excursions before, during and after exercise and a Holter ECG-E-patch to measure HRV. Psychological stress levels are assessed from Competitive State Anxiety Inventory-2.
The athletes are studied on two occasions: Day 1: 5K running competition and Day 2: 5K high intensity training session (running) in the athletes' regular training environment.
Read more
Endpoints Primary endpoints: Change in plasma glucose from start of exercise to end of exercise during competition compared to training.
Secondary endpoints: Hormonal response (cortisol, adrenalin, noradrenaline). Changes in heart rate and HRV before, during and after exercise. CGM-glucose and plasma glucose discrepancies.
Read the detailed description
Design 12 athletes with T1D and 12 healthy athletes are included in a prospective experimental randomized, cross-over study.
Screening visit Investigator Rakel Fuglsang Johansen will orally inform eligible athletes about the study at the screening visit at Steno Diabetes Center Aarhus. Individuals who have agreed to join the study (given oral and written informed consent), will have a short physically examination performed including measurement of blood pressure, height, weight, and heart and lung auscultation and screening blood samples (kidney, liver, and blood counts, lipids, and HbA1c) will be taken.
Prior to study days Within 1 month prior to the 1st study day, eligible participants will also be invited to perform a maximal incremental test to volitional exhaustion to determine their individual VO2 max. The test will be performed on a treadmill.
The athletes come to the outpatient clinic 2 days prior to the 1st study day (training or competition), where they are provided with a Dexcom G6 CGM to measure glucose excursions before, during and after exercise and a Holter ECG-E-patch to measure HRV. Instructions on food and liquid intake prior to study days are provided.
The participants are required to refrain from any intense or prolonged physical activity and alcohol consumption 48 hours prior to study days and instructed to consume a weight maintaining diet according to recommended guidelines (approx. 20 % fat, 30 % protein and 50 % carbohydrate). The participants are asked to keep a food diary and to match their food intake as accurate as possible before the two study days.
Participants with T1D should not change their insulin treatment or strategies prior to or during the study days. If the participant has experienced severe hypoglycemia (glucose measurement below 2.8 mmol/L) within 24 h hours before the study day, a new study day will be arranged. This in order to avoid that upstream hypoglycemia will affect the glucoregulatory responses during the study day, and because of the increased risk of a new hypoglycemic events.
Study days The athletes participate in a competition day and a training day in randomized order.
On the competition day, the athletes participate in a 5 km race. The last meal must be consumed at least 2 hours before the competition and the athlete is not allowed to consume anything until 1 hour after the completion of the competition, where the last blood sample will be taken. Participants with T1D should adhere to the same fasting period, but if this is not possible due to hypoglycemia, then the type and amount of food/fluid intake is recorded.
Twenty minutes before the start of the competition the initial blood samples are taken. After the athlete has completed the competition, blood sampling is repeated after 10, 20, 30, and 60 minutes. At each time point, blood samples for measurement of hormonal response (cortisol, adrenalin, noradrenaline, glucagon, insulin, growth hormone) and circulating metabolites (glucose, free fatty acids, glycerol, triglyceride, lactate) are collected. During this period, the athlete is interviewed about dietary intake within the last 24 hours and psychological stress in assessed by use of the Competitive State Anxiety Inventory-2 (SCAI-2) questionnaire. After the last blood sample has been taken, the athlete is allowed to eat and drink as usual, and the study day is completed.
On the training day, the athletes perform a 5 km high-intensity training run, but in the athletes' regular training environment without the element of competition. The time to complete the 5 km is recorded. The training sessions are performed at the same time of the day as on the competition day and the same rules apply as on the competition day regarding food and beverage intake. Blood samples are collected in the same manner as on the competition day. Once again, an interview regarding food intake and stress level is performed.
The competition day and the training day are performed three to six days apart. During the 10-day period where the CGM device is worn, data are recorded in a personal study diary listing start and end of training sessions. Food intake is recorded in the diary 24 prior to and during the study day, as well as hypoglycemic events within this period.
- Conditions
- Type 1 Diabetes, Hyperglycemia Stress
- Being tested
- 5 K running
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 K runningOther
The 5 K running competition will induce increased stress levels and thereby lead to increased levels of hyperglycemia.
| Study group | Role | What they receive |
|---|---|---|
| Competition | Active comparator | Participation in a 5 K competition (running) Receives: Other: 5 K running |
| Training | Active comparator | Performing a 5 K up-tempo training bout (running) Receives: Other: 5 K running |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose
Change in plasma glucose from start of exercise to end of exercise during competition compared to training. Level of plasma glucose at the beginning and end of competition versus training session.
Measured: Plasma glucose is measured Twenty minutes before the start of the competition until 60 minutes after the competition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start1 May 2023
- Primary completion21 Jan 2024
- Study completion1 Sep 2024
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 University of AarhusThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 12 athletes with T1D and 12 healthy athletes are included in a prospective experimental randomized, cross-over study.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esben Soendergaard, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561517
- Sponsor's protocol ID
- 94654
- Acronym
- EXCITE-1
- Status last verified
- Sep 2023
- First submitted
- 27 Sep 2022
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Competition Induced Hyperglycemia in Athletes With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05561517
- Acronym / sponsor ID
- EXCITE-1 / 94654
- Conditions
- Type 1 Diabetes, Hyperglycemia Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 21 Jan 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 30 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.
Design and methods 12 athletes with T1D and 12 healthy athletes are included in a prospective experimental randomized, cross-over study. Athletes are provided with a Dexcom G6 CGM to measure glucose excursions before, during and after exercise and a Holter ECG-E-patch to measure HRV. Psychological stress levels are assessed from Competitive State Anxiety Inventory-2.
The athletes are studied on two occasions: Day 1: 5K running competition and Day 2: 5K high intensity training session (running) in the athletes' regular training environment.
Endpoints Primary endpoints: Change in plasma glucose from start of exercise to end of exercise during competition compared to training.
Secondary endpoints: Hormonal response (cortisol, adrenalin, noradrenaline). Changes in heart rate and HRV before, during and after exercise. CGM-glucose and plasma glucose discrepancies.
Detailed description
Design 12 athletes with T1D and 12 healthy athletes are included in a prospective experimental randomized, cross-over study.
Screening visit Investigator Rakel Fuglsang Johansen will orally inform eligible athletes about the study at the screening visit at Steno Diabetes Center Aarhus. Individuals who have agreed to join the study (given oral and written informed consent), will have a short physically examination performed including measurement of blood pressure, height, weight, and heart and lung auscultation and screening blood samples (kidney, liver, and blood counts, lipids, and HbA1c) will be taken.
Prior to study days Within 1 month prior to the 1st study day, eligible participants will also be invited to perform a maximal incremental test to volitional exhaustion to determine their individual VO2 max. The test will be performed on a treadmill.
The athletes come to the outpatient clinic 2 days prior to the 1st study day (training or competition), where they are provided with a Dexcom G6 CGM to measure glucose excursions before, during and after exercise and a Holter ECG-E-patch to measure HRV. Instructions on food and liquid intake prior to study days are provided.
The participants are required to refrain from any intense or prolonged physical activity and alcohol consumption 48 hours prior to study days and instructed to consume a weight maintaining diet according to recommended guidelines (approx. 20 % fat, 30 % protein and 50 % carbohydrate). The participants are asked to keep a food diary and to match their food intake as accurate as possible before the two study days.
Participants with T1D should not change their insulin treatment or strategies prior to or during the study days. If the participant has experienced severe hypoglycemia (glucose measurement below 2.8 mmol/L) within 24 h hours before the study day, a new study day will be arranged. This in order to avoid that upstream hypoglycemia will affect the glucoregulatory responses during the study day, and because of the increased risk of a new hypoglycemic events.
Study days The athletes participate in a competition day and a training day in randomized order.
On the competition day, the athletes participate in a 5 km race. The last meal must be consumed at least 2 hours before the competition and the athlete is not allowed to consume anything until 1 hour after the completion of the competition, where the last blood sample will be taken. Participants with T1D should adhere to the same fasting period, but if this is not possible due to hypoglycemia, then the type and amount of food/fluid intake is recorded.
Twenty minutes before the start of the competition the initial blood samples are taken. After the athlete has completed the competition, blood sampling is repeated after 10, 20, 30, and 60 minutes. At each time point, blood samples for measurement of hormonal response (cortisol, adrenalin, noradrenaline, glucagon, insulin, growth hormone) and circulating metabolites (glucose, free fatty acids, glycerol, triglyceride, lactate) are collected. During this period, the athlete is interviewed about dietary intake within the last 24 hours and psychological stress in assessed by use of the Competitive State Anxiety Inventory-2 (SCAI-2) questionnaire. After the last blood sample has been taken, the athlete is allowed to eat and drink as usual, and the study day is completed.
On the training day, the athletes perform a 5 km high-intensity training run, but in the athletes' regular training environment without the element of competition. The time to complete the 5 km is recorded. The training sessions are performed at the same time of the day as on the competition day and the same rules apply as on the competition day regarding food and beverage intake. Blood samples are collected in the same manner as on the competition day. Once again, an interview regarding food intake and stress level is performed.
The competition day and the training day are performed three to six days apart. During the 10-day period where the CGM device is worn, data are recorded in a personal study diary listing start and end of training sessions. Food intake is recorded in the diary 24 prior to and during the study day, as well as hypoglycemic events within this period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 12 athletes with T1D and 12 healthy athletes are included in a prospective experimental randomized, cross-over study.
| Arm | Type | Receives |
|---|---|---|
| Competition | Active comparator | Other: 5 K runningParticipation in a 5 K competition (running) |
| Training | Active comparator | Other: 5 K runningPerforming a 5 K up-tempo training bout (running) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- T1D and healthy athletes who are otherwise healthy
- Age between 18 and 65 years
- HbA1c less than 70 mmol/mol
- The athletes must be engaged in competitive sports that includes running, and agree to participate in a local 5 km running competition within 3 months
Key exclusion criteria (3 listed)
- Proliferative retinopathy
- Hypoglycemia unawareness
- Heart disease and other conditions which may be negatively affected by the VO2 max test and study days
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 |
|---|---|---|
| 5 K runningThe 5 K running competition will induce increased stress levels and thereby lead to increased levels of hyperglycemia. | Other | Competition, Training |
Primary outcome
Plasma glucose
Time frame: Plasma glucose is measured Twenty minutes before the start of the competition until 60 minutes after the competition.
Change in plasma glucose from start of exercise to end of exercise during competition compared to training. Level of plasma glucose at the beginning and end of competition versus training session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Esben Soendergaard principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5 K running in people with Type 1 Diabetes and Hyperglycemia Stress, run by University of Aarhus at 1 site in Denmark.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 29 Jun 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma glucose (time frame: Plasma glucose is measured Twenty minutes before the start of the competition until 60 minutes after the competition.). 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 29 Jun 2026.