Status:
UNKNOWN
cArdiopulmonary exerCise Test Assessing Multiple biOmarkers and Hormones iN Type 1 diabetEs Under Different Circumstances
Lead Sponsor:
University Hospital, Antwerp
Collaborating Sponsors:
Universiteit Antwerpen
York University
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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)...
Detailed Description
This study is an extension of the Action-1 pilot study. This study is an extension of the Action-1 pilot study. The aim is to collect samples of multiple biomarkers (circulating glucose, ketones and l...
Eligibility Criteria
Inclusion
- Duration of type 1 diabetes mellitus \>5y
- Subjects willing to sign an informed consent form (ICF)
- Age 18-60y
- Using a continuous glucose monitoring system (preferably Guardian or Dexcom for CSII / Freestyle Libre for MDI)
- For CSII: only hybrid closed loop pumps (HCL)
- For MDI: only Tresiba (degludec) \& Toujeo (glargine)
- HbA1c 6-8.0% (blood result up to 3 months old)
- BMI 20-27.5 kg/m2
- The participant should be in the categories 'moderately' to 'highly physically active' according to the IPAQ score
- The Physical Activity Coefficient has not changed (from category1) in the 2 months prior to the first Exercise Test
Exclusion
- Being pregnant or having an active pregnancy wish
- Subject 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) known to have significant interference with glucose metabolism
- 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, blood result up to 12 months old)
- (Severe) food allergies as judged by the investigator
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05429359
Start Date
October 1 2022
End Date
March 31 2024
Last Update
September 6 2022
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