cArdiopulmonary exerCise Test Assessing Multiple bIOmarkers iN Type 1 Diabetes

NCT05097339 | Completed

• 1 other identifier: ACTION1
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 1

Keywords

exercise; biomarker; glucose; lactate; ketones; continuous glucose monitoring

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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)

You may qualify if:

• 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)
• % ≤ 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.
• kg/m2 \< BMI \< 25kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Indigo Diabetes NV: collaborator
• Université Montpellier: collaborator
• Campus Bio-Medico University: collaborator
• University of Padova: collaborator

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (1)

• 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.

  PMID: 35533265 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples were analysed for glucose, lactate and ketone values with YSI technology

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity; Ketosis

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Acidosis; Acid-Base Imbalance

Study Officials

• Christophe De Block, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr Christophe De Block, Head of the Department of Endocrinology, Diabetology and Metabolism, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 28, 2021
• Study Start: May 10, 2019
• Primary Completion: May 13, 2020
• Study Completion: May 13, 2020
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)