Glucose profile and physiological parameters
Conditions
Interventions
Group 1: Prospective cohort study of Paralympic triathletes before, during and after the Paris 2024 competition to analyse physiological responses and glucose dynamics using sensor technology.
The WH
Sponsors
Universität Bayreuth Sportwissenschaft IV – Exercise Physiology and Metabolism
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: -Body mass index 18.5 – 29.9 kg·m-2 -Informed consent obtained
Exclusion criteria
Exclusion criteria: - Simultaneous enrolment in any other study. - Known or suspected hypersensitivity to trial products or related products. - Receipt of any investigational medicinal product within 1 week prior to screening in this trial. - Suffering from or history of a life-threatening disease (i.e. cancer judged not to be in full remission except basal cell skin cancer or squamous cell skin cancer), or clinically severe diseases that directly influence the study results, as judged by the Investigator. This does not prohibit the participation of patients taking medications that influence the metabolism (e.g. statin) or cardio-respiratory system (e.g. asthma spray) as long as the therapy is stable and not adapted throughout the run of the trial. Furthermore, it does not exclude patients who have celiac disease (or similar diseases or allergies), if the disease is stable, and patients are able to stay on their specific diet, e.g., gluten-free. - Heart rate <35 beats per minute after resting for 5 min in supine position at screening. - Blood pressure outside the range of 90-150 mmHg for systolic or 50-95 mmHg for diastolic after resting for 5 min in supine position at screening (excluding white-coat hypertension; therefore, if a repeated measurement on a second screening visit shows values within the range, the participant can be included in the trial). This exclusion criterion also pertains to participants being on anti-hypertensives. - Significant abnormal ECG at screening as judged by the medical investigator. - Any chronic (metabolic) disorder or severe disease which, in the opinion of the investigator, might jeopardize the participant’s safety or compliance with the protocol. - History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. - Participants with mental incapacity or language barriers including adequate understanding or cooperation or who, in the opinion of their general practitioner or the investigator, should not participate in the trial. - Any condition that would interfere with trial participation or evaluation of results, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TIR3c3: Time in tight glucose range (70-120 mg/dL) in comparison of three days prior to the competition day versus the competition day versus three days after the competition day | — |
Secondary
| Measure | Time frame |
|---|---|
| -tn140: Total number of hyperglycemia (nToR; >140 mg/dL for =5 min) in comparison of three days prior to the competition day versus the competition day versus three days after the competition day (24 hours) -t>140dvn: Time above tight range (%TatR; >140 mg/dL), including readings of >250 mg/dL in comparison of three days prior to the competition day versus the competition day versus three days after the competition day -CV: Coefficient of variation (%) in comparison of three days prior to the competition day versus the competition day versus three days after the competition day -SD: Standard deviation of mean glucose in comparison of three days prior to the competition day versus the competition day versus three days after the competition day -meanglu: mean sensor glucose (mg/dL) in comparison of three days prior to the competition day versus the competition day versus three days after the competition day -eventrate>250: Extended hyperglycaemic event rate (nTaR; >250 mg/dL; for =5 min) in comparison of three days prior to the competition day versus the competition day versus three days after the competition day (nTaR; >250 mg/dL; for =15 min) -prop70-140: Proportion of participants with time in tight range (TitR; 70–140 mg/dL) for >70% in comparison of three days prior to the competition day versus the competition day versus three days after the competition day -prop140: Proportion of participants with time above tight range (TatR; >140 mg/dL) for <25% in comparison of three days prior to the competition day versus the competition day versus three days after the competition day -glunadir: Glucose nadir (mg/dL) in comparison of three days prior to the competition day versus the competition day versus three days after the competition day HRrest: Resting heart rate in comparison of three days prior to the competition day versus the competition day versus three days after the competition day -HRtrain: Heart rate during training in comparison of three days pri | — |
Countries
Germany
Contacts
Public ContactThomas Voit
Universität Bayreuth Sportwissenschaft IV – Exercise Physiology and Metabolism
Outcome results
None listed