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CompletedNCT02204670EXITUpdated Mar 31, 2016

EXIT: Prospective Study of the Response to Exercise

An observational study in Liver Fat and Type 2 Diabetes, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 12 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-31.

Sponsored by University of Manitoba · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
12 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Liver Fat
  • Type 2 Diabetes

Keywords

  • Irisin
  • Obesity
  • Exercise
  • Myokine
  • Impaired Glucose Tolerance
03

In context

Fatty Liver

1,462 studies on the registry are indexed under Fatty Liver; 289 are open to participants now.

This study's enrollment of 15 is below the median of 140 across 402 observational studies indexed under Fatty Liver.

Browse Fatty Liver studies →

Lead sponsor

University of Manitoba is the lead sponsor of 554 studies on the registry; 88 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

A community-based convenient sample of overweight adolescents aged 12-18 years with a BMI > 95th centile for age and sex.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adolescents (12-18 years)
  2. Body mass index considered obese according to the International Obesity Task Force

Exclusion criteria

Exclusion Criteria:

  1. Adolescents with medication-induced or type 1 diabetes
  2. are currently being treated with corticosteroids or atypical antipsychotics, as these agents significantly influence carbohydrate metabolism
  3. have an orthopaedic injury or chronic illness that would prevent them from performing the intervention
  4. have experienced >10% weight loss or enrolled in weight loss program within six months of enrolment
  5. a history of alcoholism or drug abuse
  6. require use of medication(s) known to affect insulin sensitivity or secretion within the last 30 days
  7. medication(s) known to cause weight gain
  8. anabolic steroids
  9. weight loss medication(s)
  10. pregnant or planning to be pregnant
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (actual)
Patient registry
No

Groups and cohorts

  • 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).

    Other: Acute release of irisin after a single exercise session.

Interventions

  • OtherAcute release of irisin after a single exercise session.

    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.

06

What researchers measure

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.

    Time frame: 6 weeks

Secondary outcomes

  1. Post-prandial glucose

    Glucose area under the curve (AUC) will be determined by summing the area under serum glucose measures between each 15- or 30-min segment using the trapezium rule during a frequently sampled 75-g oral glucose challenge .

    Time frame: 6 weeks

07

Study locations

1 site
  • The Manitoba Institute of Child Health
    Winnipeg, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02204670
Responsible party
Jon McGavock (Associate Professor Department of Pediatrics and Child Health, University of Manitoba) — Principal investigator
First posted
Jul 30, 2014
Start date
Jul 2014
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Mar 31, 2016

Study contacts

Jon M McGavock, PhD
principal investigator · University of Manitoba

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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