Competition Induced Hyperglycemia in Athletes With Type 1 Diabetes

NCT05561517 | Unknown

• 1 other identifier: 94654
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Type 1 Diabetes; Hyperglycemia Stress

Outcome Measures

Primary Outcomes (1)

• Plasma glucose

  Change in plasma glucose from start of exercise to end of exercise during competition compared to training. Level of plasma glucose at the beginning and end of competition versus training session.

  Plasma glucose is measured Twenty minutes before the start of the competition until 60 minutes after the competition.

Study Arms (2)

Competition

ACTIVE COMPARATOR

Participation in a 5 K competition (running)

Other: 5 K running

Training

ACTIVE COMPARATOR

Performing a 5 K up-tempo training bout (running)

Other: 5 K running

Interventions

5 K running OTHER

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

Competition; Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Proliferative retinopathy
• Hypoglycemia unawareness
• Heart disease and other conditions which may be negatively affected by the VO2 max test and study days

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Steno Diabetes Center Aarhus

Aarhus, Region Midt, 8200, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Esben Soendergaard

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 12 athletes with T1D and 12 healthy athletes are included in a prospective experimental randomized, cross-over study.

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: September 30, 2022
• Study Start: May 1, 2023
• Primary Completion: January 21, 2024
• Study Completion: September 1, 2024
• Last Updated: October 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)