Diabetes Mellitus, Type 1 Clinical Trial
Official title:
cArdiopulmonary exerCise Test Assessing Multiple bIOmarkers iN Type 1 Diabetes
NCT number | NCT05097339 |
Other study ID # | ACTION1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 10, 2019 |
Est. completion date | May 13, 2020 |
Verified date | October 2021 |
Source | University Hospital, Antwerp |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | May 13, 2020 |
Est. primary completion date | May 13, 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Antwerp University Hospital | Edegem | Antwerp |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Antwerp | Campus Bio-Medico University, Indigo Diabetes NV, Université Montpellier, University of Padova |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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. |
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