The Irisin and Metabolic Exercise Training Study (iMET)

November 2, 2020 updated by: Martin Senechal, University of New Brunswick
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 5A3
        • University of New Brunswick - Kinesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin Sensitivity
Time Frame: Baseline
Insulin sensitivity using the Matsuda Index.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Brunswick

Collaborators

New Brunswick Health Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

April 18, 2018

First Submitted That Met QC Criteria

April 30, 2018

First Posted (Actual)

May 2, 2018

Study Record Updates

Last Update Posted (Actual)

November 3, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University of New Brunswick

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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