cArdiopulmonary exerCise Test Assessing Multiple bIOmarkers iN Type 1 Diabetes

October 15, 2021 updated by: Christophe De Block, University Hospital, Antwerp
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • Antwerp University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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)
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
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)
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Collaborators

University of Padova
Campus Bio-Medico University
Université Montpellier
Indigo Diabetes NV

Investigators

  • Principal Investigator: Christophe De Block, MD, PhD, University Hospital, Antwerp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2019

Primary Completion (Actual)

May 13, 2020

Study Completion (Actual)

May 13, 2020

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

October 15, 2021

First Posted (Actual)

October 28, 2021

Study Record Updates

Last Update Posted (Actual)

October 28, 2021

Last Update Submitted That Met QC Criteria

October 15, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTION1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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