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Completed

NCT Number: NCT03514238

The Irisin and Metabolic Exercise Training Study

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.

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Key information

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Brunswick - Kinesiology

Fredericton, New Brunswick, E3B 5A3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Intensity Interval Aerobic Exercise (HIIT)

Behavioral

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).

Continuous Moderate Aerobic Exercise (MOD)

Behavioral

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).

Control Sitting Condition (C)

Behavioral

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

Primary outcomes

  1. Insulin Sensitivity

    Time frame: Baseline

    Insulin sensitivity using the Matsuda Index.

Sponsors and collaborators

Lead sponsor

University of New Brunswick

Other

Collaborators

  • New Brunswick Health Research Foundation

Registry information

Acronym: iMET

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 2, 2018
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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