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

NCT ID: NCT06676878

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-15
• Study Completion Date: 2026-11-01

Brief 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' health and performance.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Diabetes

The study group will consist exclusively of diabetics and they will undergo the described treadmill stress test to exhaustion.

Group Type: EXPERIMENTAL

Incremental exercise

Intervention Type: DEVICE

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.

Control

The control group will consist exclusively of healthy participants and they will undergo the described treadmill stress test to exhaustion (identical to the study group).

Group Type: ACTIVE_COMPARATOR

Incremental exercise

Intervention Type: DEVICE

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.

Interventions

Incremental exercise

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Active soccer training for at least 5 years

Exclusion Criteria

• Comorbidities significantly affecting metabolism and thermoregulation

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Paweł Korman

OTHER

Sponsor Role: lead

Responsible Party

Paweł Korman

Assistant professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anna Straburzynska-Lupa, Prof

Role: STUDY_DIRECTOR

Department of Physical Therapy and Sports Recover, Poznan University of Physical Education

Locations

Human Movement Analysis Laboratory LaBthletics Academy of Physical Education in Poznań

Poznan, Wlkp, Poland

Countries

Poland

References

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.

Reference Type: BACKGROUND

PMID: 30250851 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33467392 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35533265 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30414785 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25487370 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Informed Consent Form

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Study Documents

Document Type: Study Protocol

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Document Type: Informed Consent Form

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Other Identifiers

654/24

Identifier Type: -

Identifier Source: org_study_id