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DiabetesBCFTYRNCT06676878

Body Composition, Fitness, and Thermoregulation in Young Boys With Type I Diabetes vs. Healthy Soccer Players

A study testing Incremental exercise in people with Diabetes, run by Paweł Korman at 1 site in Poland.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The study aims to assess differences in body composition, exercise capacity, and thermoregulation between young soccer players with type 1 diabetes and their healthy peers. Real-time glycemic monitoring during exercise will provide insights for developing effective diabetes management strategies, enhancing athletes'… Read more about this study

Who is it for?
Ages 15 to 17 years, men onlyHealthy volunteers can take part
Conditions the study is for
Diabetes
What is being tested?
Incremental exercise
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePoland
Study dates
15 Feb 2026to 1 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 15 to 17 years
  • Men only
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Active soccer training for at least 5 years

Who cannot join

  • Comorbidities significantly affecting metabolism and thermoregulation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Poland1 site

  • Human Movement Analysis Laboratory LaBthletics Academy of Physical Education in Poznań

    Poznan, Wlkp, 61-871

Other trials in Poland

About this study

Official title: Assessment of Differences in Body Composition, Physical Fitness, and Thermoregulatory Response to Incremental Exercise in Young Boys With Type I Diabetes and Healthy Soccer Players

The study aims to assess differences in body composition, exercise capacity, and thermoregulation between young soccer players with type 1 diabetes and their healthy peers. Real-time glycemic monitoring during exercise will provide insights for developing effective diabetes management strategies, enhancing athletes' health and performance.

Read the detailed description

The aim of the study is to assess differences in body composition, exercise capacity, and exercise-induced thermoregulation between young athletes (soccer players) with type 1 diabetes and their healthy peers (also soccer players). Specifically, the study seeks to understand how type 1 diabetes, periodic glycemic fluctuations, and the body's metabolic balance status impact these parameters. By monitoring glycemic levels in real-time during exercise, the research will provide valuable insights into the necessity and frequency of glycemic control for individuals engaging in physical activity of varying intensities. The data obtained from this study may be crucial for developing effective strategies for managing type 1 diabetes in athletes, ultimately contributing to the improvement of their overall health and physical performance. Additionally, these findings could inform guidelines and recommendations for safe and effective exercise practices for diabetic athletes.

Conditions
Diabetes
Being tested
Incremental exercise
Keywords
diabetes, football, exercise, thermography
Medical subject headings
Diabetes Mellitus, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Incremental exerciseDevice

    A graded exercise test will be performed on a treadmill. After 3 minutes of standing on the treadmill, participants will walk at a speed of 4 km/h for the first 3 minutes, then the speed will be increased to 8 km/h. After this point, the treadmill speed will be increased by 2 km/h every 3 minutes until voluntary exhaustion.

Study groups in NCT06676878
Study groupRoleWhat they receive
DiabetesExperimentalThe study group will consist exclusively of diabetics and they will undergo the described treadmill stress test to exhaustion.
Receives: Device: Incremental exercise
ControlActive comparatorThe control group will consist exclusively of healthy participants and they will undergo the described treadmill stress test to exhaustion (identical to the study group).
Receives: Device: Incremental exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Skin temperature changes

    Thermal images of the lower limbs will be taken using a thermal camera (Flir SC 640, manufactured in the USA) before, during, and after exercise (during recovery). The assessment will be performed in degrees Celsius (°C).

    Measured: during the test

  2. Core temperature changes

    Core temperature will be measured using the eCelsius Performance system (BodyCap, France).

    Measured: Core temperature recording will start 12 hours before the exercise test and continue throughout its duration.

Secondary outcomes (1)

  1. Glycemic monitoring

    Athletes with type 1 diabetes (study group) and healthy individuals (control group) will also have a continuous glucose monitoring (CGM) sensor (Dexcom, Dexcom, Inc., San Diego, CA, USA or FreeStyle Libre, Abbott Diabetes Care, Abbott Laboratories, Abbott Park, IL, USA, or an equivalent CGM system) placed on the back of one arm (according to the manufacturer's instructions). The sensors will be applied one week before the exercise test and will remain active for 14 days. Glucose levels will be measured in milligrams per deciliter (mg/dL).

    Measured: during the test

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2024
  2. Study start15 Feb 2026 (estimated)
  3. Primary completion26 Aug 2026 (estimated)
  4. Study completion1 Jul 2027 (estimated)

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
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06676878
Sponsor's protocol ID
654/24
Acronym
BCFTYR
Status last verified
Feb 2026
First submitted
20 Oct 2024
Last updated
25 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD will be disclosed except for information that allows for the personal identification of study participants.

Publications

  • Wierzbicka E, Swiercz A, Pludowski P, Jaworski M, Szalecki M. Skeletal Status, Body Composition, and Glycaemic Control in Adolescents with Type 1 Diabetes Mellitus. J Diabetes Res. 2018 Sep 3;2018:8121634. doi: 10.1155/2018/8121634. eCollection 2018.

    PubMed 30250851

  • Mysliwiec A, Skalska M, Michalak A, Chrzanowski J, Szmigiero-Kawko M, Lejk A, Jastrzebska J, Radziminski L, Lopez-Sanchez GF, Gawrecki A, Jastrzebski Z. Responses to Low- and High-Intensity Exercise in Adolescents with Type 1 Diabetes in Relation to Their Level of VO2 Max. Int J Environ Res Public Health. 2021 Jan 15;18(2):692. doi: 10.3390/ijerph18020692.

    PubMed 33467392

  • De Ridder F, Ledeganck KJ, De Winter B, Braspenning R, Delbeke D, Renard E, Pozzilli P, Pieralice S, Vissers D, De Block C. Trends of glucose, lactate and ketones during anaerobic and aerobic exercise in subjects with type 1 diabetes: The ACTION-1 study. Diabetes Metab Res Rev. 2022 Sep;38(6):e3537. doi: 10.1002/dmrr.3537. Epub 2022 May 21.

    PubMed 35533265

  • Reddy R, Wittenberg A, Castle JR, El Youssef J, Winters-Stone K, Gillingham M, Jacobs PG. Effect of Aerobic and Resistance Exercise on Glycemic Control in Adults With Type 1 Diabetes. Can J Diabetes. 2019 Aug;43(6):406-414.e1. doi: 10.1016/j.jcjd.2018.08.193. Epub 2018 Aug 30.

    PubMed 30414785

  • McGinn R, Carter MR, Barrera-Ramirez J, Sigal RJ, Flouris AD, Kenny GP. Does type 1 diabetes alter post-exercise thermoregulatory and cardiovascular function in young adults? Scand J Med Sci Sports. 2015 Oct;25(5):e504-14. doi: 10.1111/sms.12344. Epub 2014 Dec 8.

    PubMed 25487370

Questions about this trial

What is this clinical trial studying?

A study testing Incremental exercise in people with Diabetes, run by Paweł Korman at 1 site in Poland.

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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 25 Feb 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 Poland. 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?

This study is still under way. Results are not available in the source record yet.

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?

Skin temperature changes (time frame: during the test). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06676878, which also lists 5 linked publications.

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 25 Feb 2026.

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