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Enrolling by Invitation

NCT Number: NCT06676878

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

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Key information

Age range

15 year–17 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Human Movement Analysis Laboratory LaBthletics Academy of Physical Education in Poznań

Poznan, Wlkp, 61-871, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Active soccer training for at least 5 years

Exclusion criteria

  • Comorbidities significantly affecting metabolism and thermoregulation

Treatment and study plan

Incremental exercise

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.

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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).

Other outcomes

  1. Antropometric measurement - weight

    Time frame: before test

    Body weight (kg) will be measured using a digital stadiometer (SECA 285, SECA, Hamburg, Germany).

  2. Antropometric measurement - height

    Time frame: before test

    Body height (cm) will be measured using a digital stadiometer (SECA 285, SECA, Hamburg, Germany).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

  9. 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

Paweł Korman

Other

Registry information

Official study 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

Acronym: BCFTYR

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Nov 6, 2024
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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