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Completed
NCT05561517
Competition Induced Hyperglycemia in Athletes With Type 1 Diabetes
Conditions: Type 1 Diabetes, Hyperglycemia Stress
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 24
Sponsor: University of Aarhus
Location: Steno Diabetes Center Aarhus Aarhus Region Midt
Summary
Design and methods 12 athletes with T1D and 12 healthy athletes are included in a prospective experimental randomized, cross-over study. Athletes are provided with a Dexcom G6 CGM to measure glucose excursions before, during and after exercise and a Holter ECG-E-patch to measure HRV. Psychological stress levels are assessed from Competitive State Anxiety Inventory-2.
The athletes are studied on two occasions: Day 1: 5K running competition and Day 2: 5K high intensity training session (running) in the athletes' regular training environment.
Endpoints Primary endpoints: Change in plasma glucose from start of exercise to end of exercise during competition compared to training.
Secondary endpoints: Hormonal response (cortisol, adrenalin, noradrenaline). Changes in heart rate and HRV before, during and after exercise. CGM-glucose and plasma glucose discrepancies.
Eligibility Criteria
Inclusion Criteria:
* T1D and healthy athletes who are otherwise healthy
* Age between 18 and 65 years
* HbA1c less than 70 mmol/mol
* The athletes must be engaged in competitive sports that includes running, and agree to participate in a local 5 km running competition within 3 months
Exclusion Criteria:
* Proliferative retinopathy
* Hypoglycemia unawareness
* Heart disease and other conditions which may be negatively affected by the VO2 max test and study days
Source: ClinicalTrials.gov (NCT05561517). StuddyBuddy aggregates publicly available trial information.