Clinical trial NCT02204670: EXIT: Prospective Study of the Response to Exercise
Official title: Exercise and Irisin Trial (EXIT): Prospective Cohort Study of the Determinants of the Metabolic Response to Exercise in Obese Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Fat
Type 2 Diabetes
Keywords: Irisin
Obesity
Exercise
Myokine
Impaired Glucose Tolerance
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Hepatic Triglyceride Content
timeFrame: 6 weeks
Secondary outcomes:
measure: Post-prandial glucose
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: The Manitoba Institute of Child Health
Study officials:
affiliation: University of Manitoba
name: Jon M McGavock, PhD
role: PRINCIPAL_INVESTIGATOR
References: