cArdiopulmonary exerCise Test Assessing Multiple bIOmarkers iN Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

cArdiopulmonary exerCise Test Assessing Multiple bIOmarkers iN Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05097339
• Other study ID #: ACTION1
• Status: Completed
• Start date: May 10, 2019
• Est. completion date: May 13, 2020

Study information

• Verified date: October 2021
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Campus Bio-Medico University, Indigo Diabetes NV, Université Montpellier, University of Padova

Country where clinical trial is conducted

Belgium, 

Outcome

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.