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The Irisin and Metabolic Exercise Training Study (iMET)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High Intensity Interval Aerobic Exercise (HIIT)
Continuous Moderate Aerobic Exercise (MOD)
Control Sitting Condition (C)
Sponsored by
University of New Brunswick
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Exercise, Physical Activity, Cardio-metabolic Health, Myokines, Cardiorespiratory Fitness, Obesity, Type 2 Diabetes

Eligibility Criteria

19 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of New Brunswick - Kinesiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Adults (BMI: ≥30 kg/m2)

Adults (BMI: 18.5-24.9 kg/m2)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Insulin Sensitivity
Insulin sensitivity using the Matsuda Index.

Secondary Outcome Measures

Full Information

First Posted
April 18, 2018
Last Updated
November 2, 2020
Sponsor
University of New Brunswick
Collaborators
New Brunswick Health Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03514238
Brief Title
The Irisin and Metabolic Exercise Training Study
Acronym
iMET
Official Title
The Irisin and Metabolic Exercise Training Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Brunswick
Collaborators
New Brunswick Health Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Exercise, Physical Activity, Cardio-metabolic Health, Myokines, Cardiorespiratory Fitness, Obesity, Type 2 Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adults (BMI: ≥30 kg/m2)
Arm Type
Experimental
Arm Description
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
Arm Title
Adults (BMI: 18.5-24.9 kg/m2)
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Interval Aerobic Exercise (HIIT)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Continuous Moderate Aerobic Exercise (MOD)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Control Sitting Condition (C)
Intervention Description
Blood draws matched for exercise time will be taken while participant remains seated for 35 minutes (0min, 7min, 14min, 21min, 28min, 35min).
Primary Outcome Measure Information:
Title
Insulin Sensitivity
Description
Insulin sensitivity using the Matsuda Index.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Sénéchal, PhD
Organizational Affiliation
University of New Brunswick
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Brunswick - Kinesiology
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 5A3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28453881
Citation
Fox J, Rioux BV, Goulet EDB, Johanssen NM, Swift DL, Bouchard DR, Loewen H, Senechal M. Effect of an acute exercise bout on immediate post-exercise irisin concentration in adults: A meta-analysis. Scand J Med Sci Sports. 2018 Jan;28(1):16-28. doi: 10.1111/sms.12904. Epub 2017 May 24.
Results Reference
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PubMed Identifier
29208692
Citation
Blizzard LeBlanc DR, Rioux BV, Pelech C, Moffatt TL, Kimber DE, Duhamel TA, Dolinsky VW, McGavock JM, Senechal M. Exercise-induced irisin release as a determinant of the metabolic response to exercise training in obese youth: the EXIT trial. Physiol Rep. 2017 Dec;5(23):e13539. doi: 10.14814/phy2.13539.
Results Reference
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The Irisin and Metabolic Exercise Training Study

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