Clinical trial NCT05097339: cArdiopulmonary exerCise Test Assessing Multiple bIOmarkers iN Type 1 Diabetes
Official title: cArdiopulmonary exerCise Test Assessing Multiple bIOmarkers iN Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Keywords: exercise
biomarker
glucose
lactate
ketones
continuous glucose monitoring
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Indigo Diabetes NV
name: Université Montpellier
name: Campus Bio-Medico University
name: University of Padova
First posted: 2021-10-28
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult male participants, aged 18-40 years, with Type 1 Diabetes (T1D) treated with Multiple Daily Insulin injections (MDI) and Continuous Subcutaneous Insulin Injections (CSII)

Brief summary: Collection of venous blood samples in male T1D patients to evaluate the behavior of different biomarkers (beta-hydroxybutyrate, lactate, glucose) during and after morning Aerobic (60% of VO2 max) and Symptom Limited Maximal Exercise Test.

Detailed description: Compare values and trends of different biomarkers (glucose, lactate and beta-hydroxybutyrate) before, during and after morning aerobic and symptom limited maximal exercise (cycling) to predict glycemic fluctuations (hypo- and hyperglycemic events) during and after exercise in order to create treatment algorithms to prevent these events.

Endpoint:

• Evaluate values and trends of glucose, lactate and beta-hydroxybutyrate before, during and after morning exercise in venous blood.

Eligibility criteria: Inclusion Criteria:

* Male adults (18-40 years old) with T1D, diagnosed since \> 1 year
* Using a CGM (Dexcom G5) or willing to wear a CGM (Dexcom G5) for the duration of the study.

The CGM must be applied \>48h before the exercise test

* Participants are on intensified insulin therapy (MDI) or insulin pump therapy (CSII)
* 6% ≤ HbA1c ≤ 8%
* Having a self-reported moderate activity level on the iPAQ (Internationally Physical Activity Questionnaire).
* C-peptide \<0.2 nmol/l
* The Physical Activity Coefficient has not changed in the 2 months prior to the first Exercise Test.
* 20kg/m2 \< BMI \< 25kg/m2

Exclusion Criteria:

* Recently diagnosed T1D (\< 12mo)
* Participants not on MDI or CSII
* Musculoskeletal disorder that affects cycling or is a contra-indication for vigorous physical activity
* Cardiorespiratory disease or ECG abnormality that is a contra-indication for vigorous physical activity
* Having an acute illness (e.g. influenza) that interferes with glucose metabolism
* Having a metabolic disorder (different from diabetes) or takes drugs known to have significant interference with glucose metabolism, such as systemic corticoids as judged by the investigator
* Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticoids as judged by the investigator
* Presence of concomitant pathology such as heart failure, liver failure, kidney failure defined as eGFR \<45mL/min
* Patient not able or willing to sign the patient informed consent

Primary outcomes:
measure: Change in glucose concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test
timeFrame: Blood sampling was done before the exercise, every 3 minutes for CPET and every 5 minutes for AEX during the exercise and every 15 minutes during the first hour of recovery and every 20 minutes during the rest of the 6-hour follow-up.
measure: Change in lactate concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test
timeFrame: Blood sampling was done before the exercise, every 3 minutes for CPET and every 5 minutes for AEX during the exercise and every 15 minutes during the first hour of recovery and every 20 minutes during the rest of the 6-hour follow-up.
measure: Change in ketone concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test
timeFrame: Blood sampling was done before the exercise, every 3 minutes for CPET and every 5 minutes for AEX during the exercise and every 15 minutes during the first hour of recovery and every 20 minutes during the rest of the 6-hour follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Christophe De Block, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Ridder F, Ledeganck KJ, De Winter B, Braspenning R, Delbeke D, Renard E, Pozzilli P, Pieralice S, Vissers D, De Block C. Trends of glucose, lactate and ketones during anaerobic and aerobic exercise in subjects with type 1 diabetes: The ACTION-1 study. Diabetes Metab Res Rev. 2022 Sep;38(6):e3537. doi: 10.1002/dmrr.3537. Epub 2022 May 21.