cArdiopulmonary exerCise Test Assessing Multiple biOmarkers and Hormones iN Type 1 diabetEs Under Different Circumstances

Summary

Collection of venous blood samples in 50 persons with type 1 diabetes to evaluate the behavior of different biomarkers (glucose, lactate, beta-hydroxybutyrate), and hormones (cortisol, growth hormone) during and after one morning CardioPulmonary Exercise Test and 2 aerobic (90 minutes at 40-45% of VO2 max) exercise tests under different circumstances (see Protocol).

Conditions

• Diabetes Mellitus, Type 1

Interventions

OTHER

CPET: CardioPulmonary Exercise Test for CSII users

* Baseline * VO2peak measurement * Breakfast * 100% bolus insulin * CSII users: 100% basal

OTHER

AEX1: Aerobic Exercise Test 1 for CSII users

* 90min * 40-45% VO2peak * Breakfast * 50% bolus insulin * CSII users: -2h target 150 mg/dL

OTHER

AEX2: Aerobic Exercise Test 2 for CSII users

* 90min * 40-45% VO2peak * Breakfast * 50% bolus insulin * CSII users: -1h target 150 mg/dL

OTHER

CPET: CardioPulmonary Exercise Test for MDI users

* Baseline * VO2peak measurement * Breakfast * 100% bolus insulin * MDI users: 100% basal

OTHER

AEX1: Aerobic Exercise Test 1 for MDI users

* 90min * 40-45% VO2peak * Breakfast * 50% bolus insulin * MDI users: 50% basal

OTHER

AEX2: Aerobic Exercise Test 2 for MDI users

* 90min * 40-45% VO2peak * Breakfast * 50% bolus insulin * MDI users: 80% basal

Sponsors & Collaborators

• Universiteit Antwerpen

  collaborator OTHER

• York University

  collaborator OTHER

• University Hospital, Antwerp

  lead OTHER

Principal Investigators

• Christophe De Block, MD, PhD · University Hospital, Antwerp

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-01

Primary Completion

2023-08-31

Completion

2024-03-31