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

February 23, 2026 updated by: Paweł Korman

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Wlkp
      • Poznan, Wlkp, Poland, 61-871
        • Human Movement Analysis Laboratory LaBthletics Academy of Physical Education in Poznań

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Active soccer training for at least 5 years

Exclusion Criteria:

  • Comorbidities significantly affecting metabolism and thermoregulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diabetes
The study group will consist exclusively of diabetics and they will undergo the described treadmill stress test to exhaustion.
Device: 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.
Active Comparator: 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).
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin temperature changes
Time Frame: during the test
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
Time Frame: Core temperature recording will start 12 hours before the exercise test and continue throughout its duration.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic monitoring
Time Frame: during the test
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).
during the test

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antropometric measurement - weight
Time Frame: before test
Body weight (kg) will be measured using a digital stadiometer (SECA 285, SECA, Hamburg, Germany).
before test
Antropometric measurement - height
Time Frame: before test
Body height (cm) will be measured using a digital stadiometer (SECA 285, SECA, Hamburg, Germany).
before test
Bone Mineral Density (BMD):
Time Frame: before test
Bone Mineral Density (BMD) will be measured using dual-energy X-ray absorptiometry (DXA) with the Lunar Prodigy Pro DXA device (GE Healthcare, Madison, WI, USA) and enCORE v. 16 SP1 software. BMD is expressed in grams per square centimeter (g/cm²) and indicates the density of minerals, such as calcium, in bones. All DXA scans will be performed and analyzed by the same trained technician according to the manufacturer's protocols to ensure consistency and accuracy. The procedure involves the participant lying on a table while a low-dose X-ray scans their body. The process is non-invasive and generally considered safe, with minimal exposure to radiation, comparable to the amount received during a cross-country flight.
before test
Fat Mass
Time Frame: before test
Fat Mass will be assessed using the DXA method with the Lunar Prodigy Pro DXA device and enCORE v. 16 SP1 software. This parameter is measured in kilograms (kg) or as a percentage of total body weight (%), representing the total mass of fat in the body.All DXA scans will be performed and analyzed by the same trained technician according to the manufacturer's protocols to ensure consistency and accuracy. The procedure involves the participant lying on a table while a low-dose X-ray scans their body. The process is non-invasive and generally considered safe, with minimal exposure to radiation, comparable to the amount received during a cross-country flight.
before test
Lean Mass
Time Frame: before test
Lean Mass will also be measured using the DXA method. This includes the weight of muscles, organs, and other non-fat tissues, expressed in kilograms (kg). All DXA scans will be performed and analyzed by the same trained technician according to the manufacturer's protocols to ensure consistency and accuracy. The procedure involves the participant lying on a table while a low-dose X-ray scans their body. The process is non-invasive and generally considered safe, with minimal exposure to radiation, comparable to the amount received during a cross-country flight.
before test
Ventilation
Time Frame: during test
Ventilation will be measured using an ergospirometer (Cortex Metamax 3B R2, Leipzig, Germany) and analyzed with MetasoftStudio v. 5.1.0 software (Cortex-Metamax 3B R2; Cortex Biophysik, Leipzig, Germany). The ventilation parameter will be expressed in liters per minute (L/min), which allows for the assessment of the volume of air inhaled and exhaled by the participant per minute.
during test
Oxygen Consumption (VO2)
Time Frame: during the test
Oxygen consumption (VO2) will be measured using an ergospirometer (Cortex Metamax 3B R2, Leipzig, Germany) and analyzed with MetasoftStudio v. 5.1.0 software (Cortex-Metamax 3B R2; Cortex Biophysik, Leipzig, Germany). The VO2 parameter will be expressed in milliliters per kilogram per minute (mL/kg/min), which allows for the assessment of the amount of oxygen consumed by the body per unit of body weight per minute.
during the test
Measurement Cardiovascular Parameters
Time Frame: during the test
A Polar Bluetooth Smart HR H6 heart rate monitor (Polar Electro Oy, Kempele, Finland) will be used to monitor heart rate (HR), measured in beats per minute (bpm).
during the test
Monitoring Fatigue Levels Using the RPE Scale
Time Frame: during the test

The Rating of Perceived Exertion (RPE) scale will be used to monitor fatigue levels during exercise. The RPE will be measured on a scale from 6 to 20.

Level 6 on the RPE scale indicates no exertion. This is the lowest level, suggesting that the exercise requires no physical effort.

Level 20 on the RPE scale indicates maximum exertion. This is the highest level, suggesting that the exercise is performed with the maximum possible effort, at the limit of endurance.
during the test
Lactate
Time Frame: during the test
To measure lactate accumulation, a Biosen C-line (EKF Diagnostics, Barleben, Germany) will be used. In brief, 20 µL of whole blood will be drawn into a prefilled micro test tube using a capillary. The L-lactate contained in the sample will be enzymatically converted to pyruvate and hydrogen peroxide, which will be detected by the electrode. The lactate concentration will be measured in mmol/L.
during the test
Glucose Levels from a Fingertip Blood Drop
Time Frame: during the test
To measure glucose levels, a glucose meter (e.g., Accu-Chek, Roche Diagnostics, Mannheim, Germany) will be used. In brief, a small drop of blood will be obtained from the fingertip using a lancet. The blood sample will then be placed on a test strip inserted into the glucose meter. The glucose in the sample will react with the chemicals on the strip, producing an electrical signal that will be measured by the meter. The glucose concentration will be displayed in mg/dL.
during the test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paweł Korman

Investigators

  • Study Director: Anna Straburzynska-Lupa, Prof, Department of Physical Therapy and Sports Recover, Poznan University of Physical Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2026

Primary Completion (Estimated)

August 26, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

October 20, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 654/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

09.2025 - 07.2027

IPD Sharing Access Criteria

Access to Individual Participant Data (IPD) is granted to researchers affiliated with recognized academic or healthcare institutions for legitimate scientific research purposes.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Study Data/Documents

  1. Study Protocol
  2. Informed Consent Form

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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