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The Irisin and Metabolic Exercise Training Study (iMET)

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ClinicalTrials.gov Identifier: NCT03514238
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
New Brunswick Health Research Foundation
Information provided by (Responsible Party):
Martin Senechal, University of New Brunswick

Brief Summary:
It has been established that greater amounts of vigorous intensity physical activity lead to improved health outcomes. Interestingly, the response of biologically active substances, called myokines, differs according to exercise intensity. As such, the current study aims to compare the difference in the response to irisin according to different exercise intensities in both normal weight subjects and individuals living with obesity. This study will compare continuous moderate intensity physical activity to high intensity physical activity against a control condition. Furthermore, this study will determine whether differences in exercise intensity are associated with better insulin sensitivity.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: High Intensity Interval Aerobic Exercise (HIIT) Behavioral: Continuous Moderate Aerobic Exercise (MOD) Behavioral: Control Sitting Condition (C) Not Applicable

Detailed Description:

Although exercise is recognized as a cornerstone in the management of obesity and diabetes, previous research has shown substantial inter-individual variability following an exercise intervention. As of now, the mechanisms underlying the cardio-metabolic response to exercise have not been fully elucidated. When accounting for genetic factors, only 20-30% of the response is explained, which indicates that other factors must contribute to this exercise-related cardio-metabolic response. Exercise stimulates the release of myokines, which have been shown to play a critical role in health. However, the contribution of these myokines to the cardio-metabolic response is unknown. Furthermore, the regulation of myokines according to different exercise stimuli (i.e., exercise intensity) is unclear. It is suggested that altering specific exercise parameters can reduce the variability in the response and increase the proportion of participants who obtain the expected physiological adaptations.

The purpose of this project is to: 1) determine whether high intensity interval training (HIIT) generates a greater secretion of irisin compared to moderate (MOD) aerobic exercise in individuals living with obesity and in those with a normal weight; 2) investigate whether the increase in irisin during exercise is associated with insulin sensitivity in individuals living with obesity and in those with normal weight; and 3) determine whether differences exist between groups.

Methods: The investigators will use a randomized controlled crossover design to perform this study in which 40 participants (aged 19-50) will be recruited into two groups (n = 20 obese, n = 20 normal weight). Each group will be randomized into three conditions: 1) an acute bout of MOD aerobic exercise: 35 minutes of cycling at 50% of heart rate reserve (HRR), 2) an acute bout of HIIT aerobic exercise: cycling at 50% of HRR for 5 minutes followed by 2 minutes of cycling at 85-90% of HRR consecutively for a total of 35 minutes, and 3) a control condition: blood draws matched for exercise time will be taken while the participant remains seated. The primary outcome measure will be insulin sensitivity using the Matsuda Index. The primary exposure variable will be the acute secretion of irisin during exercise.

Study hypothesis: It is hypothesized that: 1) an acute bout of HIIT aerobic exercise will generate a greater plasma irisin secretion compared an acute bout of continuous MOD aerobic exercise; 2) increased irisin will be positively associated with greater insulin sensitivity; and 3) differences will be observed between individuals living with obesity and those with a normal weight.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Irisin and Metabolic Exercise Training Study
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adults (BMI: ≥30 kg/m2)

Obese individuals will participate to three conditions:

Control Sitting Condition (C), Sitting for 35 minutes Acute Bout of Continuous Moderate Aerobic Exercise (MOD) 50-55% of heart rate reserve Acute Bout of High Intensity Interval Aerobic Exercise (HIIT) 85-90% heart rate reserve

Behavioral: High Intensity Interval Aerobic Exercise (HIIT)

Cycling at 50-55% heart rate reserve for 5 minutes followed by 2 minutes of cycling at 85-90% heart rate reserve consecutively for a total of 35 minutes.

Blood draws will occur at 6 different time points during exercise (0min, 7min, 14min, 21min, 28min, 35min).


Behavioral: Continuous Moderate Aerobic Exercise (MOD)
35 minutes of cycling at 50-55% heart rate reserve. Blood draws will occur at 6 different time points during exercise (0min, 7min, 14min, 21min, 28min, 35min).

Behavioral: Control Sitting Condition (C)
Blood draws matched for exercise time will be taken while participant remains seated for 35 minutes (0min, 7min, 14min, 21min, 28min, 35min).

Experimental: Adults (BMI: 18.5-24.9 kg/m2)

Normal weight individuals will participate to three conditions:

Control Sitting Condition (C), Sitting for 35 minutes Acute Bout of Continuous Moderate Aerobic Exercise (MOD) 50-55% of heart rate reserve Acute Bout of High Intensity Interval Aerobic Exercise (HIIT) 85-90% heart rate reserve

Behavioral: High Intensity Interval Aerobic Exercise (HIIT)

Cycling at 50-55% heart rate reserve for 5 minutes followed by 2 minutes of cycling at 85-90% heart rate reserve consecutively for a total of 35 minutes.

Blood draws will occur at 6 different time points during exercise (0min, 7min, 14min, 21min, 28min, 35min).


Behavioral: Continuous Moderate Aerobic Exercise (MOD)
35 minutes of cycling at 50-55% heart rate reserve. Blood draws will occur at 6 different time points during exercise (0min, 7min, 14min, 21min, 28min, 35min).

Behavioral: Control Sitting Condition (C)
Blood draws matched for exercise time will be taken while participant remains seated for 35 minutes (0min, 7min, 14min, 21min, 28min, 35min).




Primary Outcome Measures :
  1. Insulin Sensitivity [ Time Frame: Baseline ]
    Insulin sensitivity using the Matsuda Index.



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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Obesity (≥30 kg/m2);
  • Physical inactivity (must not reach Canadian Physical Activity Guidelines);
  • At risk for Type 2 diabetes;
  • Adult (aged 19-50).

Exclusion Criteria:

  • Individuals with Type 2 diabetes;
  • Chronic conditions or injuries that would impact exercise;
  • Regular exercise training.

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): NCT03514238


Contacts
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Contact: Martin Sénéchal, PhD 506-451-6889 msenecha@unb.ca

Locations
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Canada, New Brunswick
University of New Brunswick - Kinesiology Recruiting
Fredericton, New Brunswick, Canada, E3B 5A3
Contact: Martin Sénéchal, PhD    506-451-6889    msenech@unb.ca   
Sponsors and Collaborators
University of New Brunswick
New Brunswick Health Research Foundation
Investigators
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Principal Investigator: Martin Sénéchal, PhD University of New Brunswick

Publications:
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Responsible Party: Martin Senechal, Assistant Professor, University of New Brunswick
ClinicalTrials.gov Identifier: NCT03514238     History of Changes
Other Study ID Numbers: University of New Brunswick
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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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 Martin Senechal, University of New Brunswick:
Exercise
Physical Activity
Cardio-metabolic Health
Myokines
Cardiorespiratory Fitness
Obesity
Type 2 Diabetes
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms