NCT02204670

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

1.3 years

First QC Date

July 28, 2014

Last Update Submit

March 29, 2016

Conditions

Keywords

IrisinObesityExerciseMyokineImpaired Glucose Tolerance

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).

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

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.

Overweight Adolescents Performing Resistance Training

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

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

Location

MeSH Terms

Conditions

Fatty LiverDiabetes Mellitus, Type 2ObesityMotor ActivityGlucose Intolerance

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorHyperglycemia

Study Officials

  • Jon M McGavock, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

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

Locations