EXIT: Prospective Study of the Response to Exercise
EXIT
Exercise and Irisin Trial (EXIT): Prospective Cohort Study of the Determinants of the Metabolic Response to Exercise in Obese Adolescents
1 other identifier
observational
15
1 country
1
Brief Summary
Background : Regular exercise is a cornerstone in the prevention and the management of comorbidities. Unfortunately, the metabolic benefit of exercise training is not universal and varies among individuals. A main factor likely to explain the exercise training variability is the lack of empirical evidence on the determinants of exercise training. A series of muscle-derived cytokines have recently been discovered that (1) are released during exercise and (2) exert positive effects on peripheral tissues. Irisin is one of these novel "myokines" and might contributes to the metabolic adaptations to exercise training. Methods: The investigators will perform a pilot cohort study in which obese adolescents will perform resistance exercise training for 6 weeks. The main exposure variable will be the acute release of irisin during resistance exercise. The main outcome measures will be the change in hepatic triglyceride content and glucose area under the curve during a 75g, 2-hour oral glucose tolerance test. Study Hypothesis: The primary overall hypothesis is that the change in plasma Irisin with a single bout of exercise will be associated with the metabolic adaptations to 6 weeks of resistance training, specifically, the reductions in hepatic triglyceride content and post-prandial glucose excursions, in obese adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 28, 2014
CompletedFirst Posted
Study publicly available on registry
July 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedMarch 31, 2016
March 1, 2016
1.3 years
July 28, 2014
March 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hepatic Triglyceride Content
Hepatic triglyceride content will be measured by using 1H magnetic resonance spectroscopy. After image acquisition, a single voxel volume of interest will be placed in the upper right lobe of the liver in an area devoid of adipose tissue to acquire 1H spectra. A total of 64 spectra will be collected and averaged to determine the intracellular triglyceride content.
6 weeks
Secondary Outcomes (1)
Post-prandial glucose
6 weeks
Study Arms (1)
Overweight Adolescents Performing Resistance Training
Overweight adolescents that meet pre-specified enrollment criteria will all undergo supervised resistance exercise for a 6-week period. Prior to training, all participants will undergo a single bout of resistance training to determine the acute release of Irisin with resistance training. This will be the primary exposure variable. After the acute session, all participants will perform resistance training three times per week for a period of 4 weeks. During each session participants will perform 3 sets of 8-12 repetitions (60-85% of 1RM) for major muscle groups (quadriceps, shoulders, and pectoral).
Interventions
We will determine the amount of Irisin secreted after a single bout of resistance exercise. Participants will be stratified into 3 groups based on the degree of Irisin release during this acute bout of resistance exercise. The metabolic adaptations to the 4 weeks of resistance training will be compared between youth stratified according to the amount of Irisin released during the acute bout of resistance exercise.
Eligibility Criteria
A community-based convenient sample of overweight adolescents aged 12-18 years with a BMI \> 95th centile for age and sex.
You may qualify if:
- Adolescents (12-18 years)
- Body mass index considered obese according to the International Obesity Task Force
You may not qualify if:
- Adolescents with medication-induced or type 1 diabetes
- are currently being treated with corticosteroids or atypical antipsychotics, as these agents significantly influence carbohydrate metabolism
- have an orthopaedic injury or chronic illness that would prevent them from performing the intervention
- have experienced \>10% weight loss or enrolled in weight loss program within six months of enrolment
- a history of alcoholism or drug abuse
- require use of medication(s) known to affect insulin sensitivity or secretion within the last 30 days
- medication(s) known to cause weight gain
- anabolic steroids
- weight loss medication(s)
- pregnant or planning to be pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Manitoba Institute of Child Health
Winnipeg, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jon M McGavock, PhD
University of Manitoba
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor Department of Pediatrics and Child Health
Study Record Dates
First Submitted
July 28, 2014
First Posted
July 30, 2014
Study Start
July 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
March 31, 2016
Record last verified: 2016-03