cArdiopulmonary exerCise Test Assessing Multiple bIOmarkers iN Type 1 Diabetes

Study Overview
=================
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.

Official Title
-----------------
cArdiopulmonary exerCise Test Assessing Multiple bIOmarkers iN Type 1 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 1

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with type 1 diabetes<br>Patients with type 1 diabetes perform a morning Symptom Limited Maximal Exercise Test (CPET) or a 60-minute morning Aerobic Test (AEX) at 60% VO2peak | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glucose concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test | 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) | 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. | 
| Change in lactate concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test | 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) | 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. | 
| Change in ketone concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test | 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) | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, biomarker, glucose, lactate, ketones, continuous glucose monitoring