ObesityiMETNCT03514238
The Irisin and Metabolic Exercise Training Study
A study testing High Intensity Interval Aerobic Exercise (HIIT) and Continuous Moderate Aerobic Exercise (MOD) in people with Obesity, run by University of New Brunswick at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- High Intensity Interval Aerobic Exercise (HIIT) and Continuous Moderate Aerobic Exercise (MOD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2017to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Obesity (≥30 kg/m2);
- Physical inactivity (must not reach Canadian Physical Activity Guidelines);
- At risk for Type 2 diabetes;
- Adult (aged 19-50).
Who cannot join
- Individuals with Type 2 diabetes;
- Chronic conditions or injuries that would impact exercise;
- Regular exercise training.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of New Brunswick - Kinesiology
Fredericton, New Brunswick, E3B 5A3
About this 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- High Intensity Interval Aerobic Exercise (HIIT), Continuous Moderate Aerobic Exercise (MOD), Control Sitting Condition (C)
- Keywords
- Exercise, Physical Activity, Cardio-metabolic Health, Myokines, Cardiorespiratory Fitness, Obesity, Type 2 Diabetes
- Medical subject headings
- Obesity, Motor Activity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval Aerobic Exercise (HIIT)Behavioural
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)Behavioural
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)Behavioural
Blood draws matched for exercise time will be taken while participant remains seated for 35 minutes (0min, 7min, 14min, 21min, 28min, 35min).
| Study group | Role | What they receive |
|---|---|---|
| Adults (BMI: ≥30 kg/m2) | Experimental | 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 Receives: Behavioral: High Intensity Interval Aerobic Exercise (HIIT); Behavioral: Continuous Moderate Aerobic Exercise (MOD); Behavioral: Control Sitting Condition (C) |
| Adults (BMI: 18.5-24.9 kg/m2) | Experimental | 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 Receives: Behavioral: High Intensity Interval Aerobic Exercise (HIIT); Behavioral: Continuous Moderate Aerobic Exercise (MOD); Behavioral: Control Sitting Condition (C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Insulin sensitivity using the Matsuda Index.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start1 Sep 2017
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Brunswick
- Sponsor type
- University, hospital or other
- Collaborators
- New Brunswick Health Research Foundation
- Responsible party
- Principal investigator, Martin Senechal, University of New Brunswick
- Investigators
- Martin Sénéchal, PhD, Principal investigator, University of New Brunswick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514238
- Sponsor's protocol ID
- University of New Brunswick
- Acronym
- iMET
- Status last verified
- Nov 2020
- First submitted
- 18 Apr 2018
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28453881Blizzard 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.
PubMed 29208692Rioux B, Paudel Y, Thomson A, Peskett L, Senechal M. An examination of exercise intensity and its impact on the acute release of irisin across obesity status: a randomized controlled crossover trial. Appl Physiol Nutr Metab. 2024 Dec 1;49(12):1712-1728. doi: 10.1139/apnm-2024-0091. Epub 2024 Sep 3.
PubMed 39226615
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Irisin and Metabolic Exercise Training Study
- ClinicalTrials.gov ID
- NCT03514238
- Acronym / sponsor ID
- iMET / University of New Brunswick
- Conditions
- Obesity
- Keywords
- Exercise, Physical Activity, Cardio-metabolic Health, Myokines, Cardiorespiratory Fitness, Obesity, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of New BrunswickUniversity, hospital or other
- Collaborators
- New Brunswick Health Research Foundation
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults (BMI: ≥30 kg/m2) | Experimental | Behavioral: High Intensity Interval Aerobic Exercise (HIIT), Behavioral: Continuous Moderate Aerobic Exercise (MOD), Behavioral: Control Sitting Condition (C)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 |
| Adults (BMI: 18.5-24.9 kg/m2) | Experimental | Behavioral: High Intensity Interval Aerobic Exercise (HIIT), Behavioral: Continuous Moderate Aerobic Exercise (MOD), Behavioral: Control Sitting Condition (C)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 |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Obesity (≥30 kg/m2);
- Physical inactivity (must not reach Canadian Physical Activity Guidelines);
- At risk for Type 2 diabetes;
- Adult (aged 19-50).
Key exclusion criteria (3 listed)
- Individuals with Type 2 diabetes;
- Chronic conditions or injuries that would impact exercise;
- Regular exercise training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Adults (BMI: 18.5-24.9 kg/m2), Adults (BMI: ≥30 kg/m2) |
| 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). | Behavioural | Adults (BMI: 18.5-24.9 kg/m2), Adults (BMI: ≥30 kg/m2) |
| 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). | Behavioural | Adults (BMI: 18.5-24.9 kg/m2), Adults (BMI: ≥30 kg/m2) |
Primary outcome
Insulin Sensitivity
Time frame: Baseline
Insulin sensitivity using the Matsuda Index.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Background: PubMed 28453881Fox 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.
- Background: PubMed 29208692Blizzard 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.
- Derived from this study: PubMed 39226615Rioux B, Paudel Y, Thomson A, Peskett L, Senechal M. An examination of exercise intensity and its impact on the acute release of irisin across obesity status: a randomized controlled crossover trial. Appl Physiol Nutr Metab. 2024 Dec 1;49(12):1712-1728. doi: 10.1139/apnm-2024-0091. Epub 2024 Sep 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Sénéchal, PhD principal investigator
University of New Brunswick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Aerobic Exercise (HIIT) and Continuous Moderate Aerobic Exercise (MOD) in people with Obesity, run by University of New Brunswick at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Sensitivity (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03514238, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020; AzTrials last refreshed its copy on 31 Oct 2026.