NCT06676878

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
13mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Feb 2026Jul 2027

First Submitted

Initial submission to the registry

October 20, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 6, 2024

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2026

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

October 20, 2024

Last Update Submit

February 23, 2026

Conditions

Keywords

diabetesfootballexercisethermography

Outcome Measures

Primary Outcomes (2)

  • 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).

    during the test

  • Core temperature changes

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

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

Secondary Outcomes (1)

  • Glycemic monitoring

    during the test

Other Outcomes (11)

  • Antropometric measurement - weight

    before test

  • Antropometric measurement - height

    before test

  • Bone Mineral Density (BMD):

    before test

  • +8 more other outcomes

Study Arms (2)

Diabetes

EXPERIMENTAL

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

Device: Incremental exercise

Control

ACTIVE COMPARATOR

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).

Device: Incremental exercise

Interventions

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.

ControlDiabetes

Eligibility Criteria

Age15 Years - 17 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Active soccer training for at least 5 years

You may not qualify if:

  • Comorbidities significantly affecting metabolism and thermoregulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Movement Analysis Laboratory LaBthletics Academy of Physical Education in Poznań

Poznan, Wlkp, 61-871, Poland

Location

Related Publications (5)

  • 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.

    PMID: 30250851BACKGROUND
  • 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.

    PMID: 33467392BACKGROUND
  • 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.

    PMID: 35533265BACKGROUND
  • 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.

    PMID: 30414785BACKGROUND
  • 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.

    PMID: 25487370BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusMotor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Anna Straburzynska-Lupa, Prof

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 20, 2024

First Posted

November 6, 2024

Study Start

February 15, 2026

Primary Completion (Estimated)

August 26, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

All IPD will be disclosed except for information that allows for the personal identification of study participants.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
09.2025 - 07.2027
Access Criteria
Access to Individual Participant Data (IPD) is granted to researchers affiliated with recognized academic or healthcare institutions for legitimate scientific research purposes.

Available IPD Datasets

Study Protocol Access
Informed Consent Form Access

Locations