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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Denmark1 site
  • Steno Diabetes Center Aarhus

    Aarhus, Region Midt, 8200

Other trials in Denmark

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.

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 groups in NCT05561517
Study groupRoleWhat they receive
CompetitionActive comparatorParticipation in a 5 K competition (running)
Receives: Other: 5 K running
TrainingActive comparatorPerforming 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.

  1. 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.

  1. First posted30 Sep 2022
  2. Study start1 May 2023
  3. Primary completion21 Jan 2024
  4. Study completion1 Sep 2024

Resources

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)
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

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.

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