cArdiopulmonary exerCise Test Assessing Multiple biOmarkers and Hormones iN Type 1 diabetEs Under Different Circumstances

NCT05429359 | Unknown

• 1 other identifier: ACT-ONE
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Collection of venous blood samples in 50 persons with type 1 diabetes to evaluate the behavior of different biomarkers (glucose, lactate, beta-hydroxybutyrate), and hormones (cortisol, growth hormone) during and after one morning CardioPulmonary Exercise Test and 2 aerobic (90 minutes at 40-45% of VO2 max) exercise tests under different circumstances (see Protocol).

Conditions

Diabetes Mellitus, Type 1

Keywords

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

Outcome Measures

Primary Outcomes (1)

• CGM outcomes during and after morning exercise

  CGM outcomes, determined as: * Time in range (TIR) 70-180mg/dL * Time below range (TBR) Level 2, \<54 mg/dL * Time below range (TBR) Level 1 and 2, \<70 mg/dL * Time above range (TAR) Level 1 and 2, \>180 mg/dL * Time above range (TAR) Level 2, \>250 mg/dL

  CGM values will be collected up to 8 hours prior to the exercise test and 24 hours after the exercise test

Secondary Outcomes (5)

• Change in glucose concentration in venous blood during and after morning exercise test

  Blood sampling was done before the exercise, every 3-10 minutes during the exercise and every 15 minutes during the first hour of recovery and every 30-60 minutes during the rest of the 6-hour follow-up

• Change in lactate concentration in venous blood during and after morning exercise test

  Blood sampling was done before the exercise, every 3-10 minutes during the exercise and every 15 minutes during the first hour of recovery and every 30-60 minutes during the rest of the 6-hour follow-up

• Change in ketone concentration in venous blood during and after morning exercise test

  Blood sampling was done before the exercise, every 3-10 minutes during the exercise and every 15 minutes during the first hour of recovery and every 30-60 minutes during the rest of the 6-hour follow-up

• Change in cortisol concentration in venous blood during and after morning exercise test

  Blood sampling was done before the exercise, every 15-30 minutes during the exercise and every 15-30 minutes during the first hour of recovery and every 60-120 minutes during the rest of the 6-hour follow-up

• Change in growth hormone concentration in venous blood during and after morning exercise test

  Blood sampling was done before the exercise, every 15-30 minutes during the exercise and every 15-30 minutes during the first hour of recovery and every 60-120 minutes during the rest of the 6-hour follow-up

Study Arms (2)

CSII users

ACTIVE COMPARATOR

Patients using Continuous Subcutaneous Insulin Infusion (only hybrid closed loop pumps)

Other: CPET: CardioPulmonary Exercise Test for CSII users; Other: AEX1: Aerobic Exercise Test 1 for CSII users; Other: AEX2: Aerobic Exercise Test 2 for CSII users

MDI users

ACTIVE COMPARATOR

Patients using Multiple Daily Injections (only Tresiba and Toujeo as basal insulin)

Other: CPET: CardioPulmonary Exercise Test for MDI users; Other: AEX1: Aerobic Exercise Test 1 for MDI users; Other: AEX2: Aerobic Exercise Test 2 for MDI users

Interventions

CPET: CardioPulmonary Exercise Test for CSII users OTHER

* Baseline * VO2peak measurement * Breakfast * 100% bolus insulin * CSII users: 100% basal

CSII users

AEX1: Aerobic Exercise Test 1 for CSII users OTHER

* 90min * 40-45% VO2peak * Breakfast * 50% bolus insulin * CSII users: -2h target 150 mg/dL

CSII users

AEX2: Aerobic Exercise Test 2 for CSII users OTHER

* 90min * 40-45% VO2peak * Breakfast * 50% bolus insulin * CSII users: -1h target 150 mg/dL

CSII users

CPET: CardioPulmonary Exercise Test for MDI users OTHER

* Baseline * VO2peak measurement * Breakfast * 100% bolus insulin * MDI users: 100% basal

MDI users

AEX1: Aerobic Exercise Test 1 for MDI users OTHER

* 90min * 40-45% VO2peak * Breakfast * 50% bolus insulin * MDI users: 50% basal

MDI users

AEX2: Aerobic Exercise Test 2 for MDI users OTHER

* 90min * 40-45% VO2peak * Breakfast * 50% bolus insulin * MDI users: 80% basal

MDI users

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Duration of type 1 diabetes mellitus \>5y
• Subjects willing to sign an informed consent form (ICF)
• Age 18-60y
• Using a continuous glucose monitoring system (preferably Guardian or Dexcom for CSII / Freestyle Libre for MDI)
• For CSII: only hybrid closed loop pumps (HCL)
• For MDI: only Tresiba (degludec) \& Toujeo (glargine)
• HbA1c 6-8.0% (blood result up to 3 months old)
• BMI 20-27.5 kg/m2
• The participant should be in the categories 'moderately' to 'highly physically active' according to the IPAQ score
• The Physical Activity Coefficient has not changed (from category1) in the 2 months prior to the first Exercise Test

You may not qualify if:

• Being pregnant or having an active pregnancy wish
• Subject 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) known to have significant interference with glucose metabolism
• 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, blood result up to 12 months old)
• (Severe) food allergies as judged by the investigator

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Universiteit Antwerpen: collaborator
• York University: collaborator

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

Central Study Contacts

Christophe De Block, MD, PhD

CONTACT

+3238214364; christophe.deblock@uza.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 23, 2022
• Study Start: October 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: March 31, 2024
• Last Updated: September 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share