Diabetes Mellitus, Type 1NCT05097339
cArdiopulmonary exerCise Test Assessing Multiple bIOmarkers iN Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1, run by University Hospital, Antwerp at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Diabetes Mellitus, Type 1
- How many people
- 21 participants
- Where
- 1 siteBelgium
- Study dates
- 10 May 2019to 13 May 2020
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- No healthy volunteers
- Adult
Study population: Adult male participants, aged 18-40 years, with Type 1 Diabetes (T1D) treated with Multiple Daily Insulin injections (MDI) and Continuous Subcutaneous Insulin Injections (CSII)
Who may be able to join
- 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).
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- exercise, biomarker, glucose, lactate, ketones, continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 1 diabetes | 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start10 May 2019
- Primary completion13 May 2020
- Study completion13 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Indigo Diabetes NV, Université Montpellier, Campus Bio-Medico University, University of Padova
- Responsible party
- Principal investigator, Christophe De Block, University Hospital, Antwerp
- Investigators
- Christophe De Block, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097339
- Sponsor's protocol ID
- ACTION1
- Status last verified
- Oct 2021
- First submitted
- 22 Sep 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Ridder F, Ledeganck KJ, De Winter B, Braspenning R, Delbeke D, Renard E, Pozzilli P, Pieralice S, Vissers D, De Block C. Trends of glucose, lactate and ketones during anaerobic and aerobic exercise in subjects with type 1 diabetes: The ACTION-1 study. Diabetes Metab Res Rev. 2022 Sep;38(6):e3537. doi: 10.1002/dmrr.3537. Epub 2022 May 21.
PubMed 35533265
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- cArdiopulmonary exerCise Test Assessing Multiple bIOmarkers iN Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05097339
- Acronym / sponsor ID
- ACTION1
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- exercise, biomarker, glucose, lactate, ketones, continuous glucose monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Indigo Diabetes NV, Université Montpellier, Campus Bio-Medico University, University of Padova
- Study start
- 10 May 2019 (actual)
- Primary completion
- 13 May 2020 (actual)
- Study completion
- 13 May 2020 (actual)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with type 1 diabetes | – | –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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult male participants, aged 18-40 years, with Type 1 Diabetes (T1D) treated with Multiple Daily Insulin injections (MDI) and Continuous Subcutaneous Insulin Injections (CSII)
Key inclusion criteria (9 listed)
- 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%
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in glucose concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test
Time frame: 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
Time frame: 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
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Derived from this study: PubMed 35533265De Ridder F, Ledeganck KJ, De Winter B, Braspenning R, Delbeke D, Renard E, Pozzilli P, Pieralice S, Vissers D, De Block C. Trends of glucose, lactate and ketones during anaerobic and aerobic exercise in subjects with type 1 diabetes: The ACTION-1 study. Diabetes Metab Res Rev. 2022 Sep;38(6):e3537. doi: 10.1002/dmrr.3537. Epub 2022 May 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe De Block, MD, PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glucose concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05097339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.