Competition Induced Hyperglycemia in Athletes With Type 1 Diabetes

NCT05561517 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-10-25

No results posted yet for this study

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.

Conditions

Interventions

OTHER

5 K running

The 5 K running competition will induce increased stress levels and thereby lead to increased levels of hyperglycemia.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Esben Soendergaard · University of Aarhus

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2024-01-21
Completion
2024-09-01

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05561517 on ClinicalTrials.gov