cArdiopulmonary exerCise Test Assessing Multiple bIOmarkers iN Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-10

Study Completion Date

2020-05-13

Brief Summary

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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

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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

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Diabetes Mellitus, Type 1

Keywords

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exercise biomarker glucose lactate ketones continuous glucose monitoring

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Christophe De Block

Prof Dr Christophe De Block, Head of the Department of Endocrinology, Diabetology and Metabolism, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christophe De Block, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

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Antwerp University Hospital

Edegem, Antwerp, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED

PMID: 35533265 (View on PubMed)

Other Identifiers

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ACTION1

Identifier Type: -

Identifier Source: org_study_id