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cArdiopulmonary exerCise Test Assessing Multiple biOmarkers and Hormones iN Type 1 diabetEs Under Different Circumstances (ACT-ONE)

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ClinicalTrials.gov Identifier: NCT05429359
Recruitment Status : Not yet recruiting
First Posted : June 23, 2022
Last Update Posted : July 13, 2022
Sponsor:
Collaborators:
Universiteit Antwerpen
York University
Information provided by (Responsible Party):
University Hospital, Antwerp

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).

Condition or disease
Diabetes Mellitus, Type 1

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Days
Official Title: cArdiopulmonary exerCise Test Assessing Multiple biOmarkers and Hormones iN Type 1 diabetEs Under Different Circumstances (ACT-ONE)
Estimated Study Start Date : August 1, 2022
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with type 1 diabetes using CSII (only hybrid closed loop pumps)

CPET:

  • Baseline
  • VO2peak measurement
  • Breakfast
  • 100% bolus insulin
  • CSII: 100% basal

AEX1:

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

AEX2:

  • 90min
  • 40-45% VO2peak
  • Breakfast
  • 50% bolus insulin
  • CSII: -1h target 150 mg/dL
Patients with type 1 diabetes using MDI (only Tresiba and Toujeo)

CPET:

  • Baseline
  • VO2peak measurement
  • Breakfast
  • 100% bolus insulin
  • MDI: 100% basal

AEX1:

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

AEX2:

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



Primary Outcome Measures :
  1. CGM outcomes during and after morning exercise [ Time Frame: CGM values will be collected up to 8 hours prior to the exercise test and 24 hours after the exercise test ]

    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


Secondary Outcome Measures :
  1. Change in glucose concentration in venous blood during and after morning exercise test [ Time Frame: 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 ]
    Glucose levels in mg/dL during and after CardioPulmonary Exercise Test and 2 morning Aerobic Exercise Tests (90 minutes at 40-45% of VO2 max) (CPET & AEX1-2), measured through EKF

  2. Change in lactate concentration in venous blood during and after morning exercise test [ Time Frame: 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 ]
    Lactate levels in mM during and after CardioPulmonary Exercise Test and 2 morning Aerobic Exercise Tests (90 minutes at 40-45% of VO2 max) (CPET & AEX1-2), measured through EKF

  3. Change in ketone concentration in venous blood during and after morning exercise test [ Time Frame: 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 ]
    Ketone (Beta-hydroxybutyrate) levels in mM during and after CardioPulmonary Exercise Test and 2 morning Aerobic Exercise Tests (90 minutes at 40-45% of VO2 max) (CPET & AEX1-2), measured through EKF

  4. Change in cortisol concentration in venous blood during and after morning exercise test [ Time Frame: 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 ]
    Cortisol levels during and after CardioPulmonary Exercise Test and 2 morning Aerobic Exercise Tests (90 minutes at 40-45% of VO2 max) (CPET & AEX1-2), measured through venous blood sampling analysis

  5. Change in growth hormone concentration in venous blood during and after morning exercise test [ Time Frame: 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 ]
    Growth hormone levels during and after CardioPulmonary Exercise Test and 2 morning Aerobic Exercise Tests (90 minutes at 40-45% of VO2 max) (CPET & AEX1-2), measured through venous blood sampling analysis


Biospecimen Retention:   Samples Without DNA
Venous blood samples (to analyse for glucose, lactate and ketone values and cortisol and growth hormone)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
50 adult participants, with Type 1 Diabetes (T1D) with Multiple Daily Insulin injections (MDI) or Continuous Subcutaneous Insulin Injections (CSII) in an equal ratio of 25 MDI and 25 CSII users.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05429359


Contacts
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Contact: Christophe De Block, MD, PhD +3238214364 christophe.deblock@uza.be

Sponsors and Collaborators
University Hospital, Antwerp
Universiteit Antwerpen
York University
Investigators
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Principal Investigator: Christophe De Block, MD, PhD University Hospital, Antwerp
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Responsible Party: University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT05429359    
Other Study ID Numbers: ACT-ONE
First Posted: June 23, 2022    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Antwerp:
exercise
biomarker
glucose
lactate
ketones
continuous glucose monitoring
hormones
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases