Diabetes Mellitus, Type 1
Conditions
Keywords
exercise, biomarker, glucose, lactate, ketones, continuous glucose monitoring
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.
Interventions
None listed
Sponsors
Indigo Diabetes NV
Université Montpellier
Campus Bio-Medico University
University of Padova
University Hospital, Antwerp
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glucose concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test | 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. | Glucose levels in mg/dL during and after morning Aerobic (60 minutes at 60% of VO2 max) and Symptom Limited Maximal Exercise Test (AEX & CPET), measured in 21 patients through YSI (YSI Life Sciences, Yellow Springs, OH) |
| Change in lactate concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test | 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. | Lactate levels in mmol/mol during and after morning Aerobic (60 minutes at 60% of VO2 max) and Symptom Limited Maximal Exercise Test (AEX & CPET), measured in 21 patients through YSI (YSI Life Sciences, Yellow Springs, OH) |
| Change in ketone concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test | 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. | Ketone levels (Beta-hydroxybutyrate) in mmol/mol during and after morning Aerobic (60 minutes at 60% of VO2 max) and Symptom Limited Maximal Exercise Test (AEX & CPET), measured in 21 patients through YSI (YSI Life Sciences, Yellow Springs, OH) |
Countries
Belgium
Outcome results
None listed