An interventional study of Incremental exercise in Diabetes, sponsored by Paweł Korman. Enrolling by invitation at 1 site in Poland. Open to male participants aged 15 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-25.
Sponsored by Paweł Korman · Not applicable, Interventional, and Diagnostic
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →This is the only study on the registry with Paweł Korman as lead sponsor.
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Exclusion Criteria:
The study group will consist exclusively of diabetics and they will undergo the described treadmill stress test to exhaustion.
Device: Incremental exercise
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.
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).
Time frame: during the test
Core temperature changes
Core temperature will be measured using the eCelsius Performance system (BodyCap, France).
Time frame: Core temperature recording will start 12 hours before the exercise test and continue throughout its duration.
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).
Time frame: during the test
Antropometric measurement - weight
Body weight (kg) will be measured using a digital stadiometer (SECA 285, SECA, Hamburg, Germany).
Time frame: before test
Antropometric measurement - height
Body height (cm) will be measured using a digital stadiometer (SECA 285, SECA, Hamburg, Germany).
Time frame: before test
Bone Mineral Density (BMD):
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.
Time frame: before test
Fat Mass
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.
Time frame: before test
Lean Mass
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.
Time frame: before test
Ventilation
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.
Time frame: during test
Oxygen Consumption (VO2)
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.
Time frame: during the test
Measurement Cardiovascular Parameters
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).
Time frame: during the test
Monitoring Fatigue Levels Using the RPE Scale
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.
Time frame: during the test
Lactate
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.
Time frame: during the test
Glucose Levels from a Fingertip Blood Drop
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.
Time frame: during the test
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Plan to share: Yes — All IPD will be disclosed except for information that allows for the personal identification of study participants.
Supporting information: Study protocol, Icf
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