EXIT: Prospective Study of the Response to Exercise

Completed

• Conditions: Liver Fat; Type 2 Diabetes
• Interventions: Other: Acute release of irisin after a single exercise session.

• Registration Number: NCT02204670
• Lead Sponsor: University of Manitoba

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-29
• Study First Posted: 2014-07-30
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Overweight Adolescents Performing Resistance Training	Acute release of irisin after a single exercise session.	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).

Primary Outcome Measures

Name	Time	Method
Hepatic Triglyceride Content	6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Post-prandial glucose	6 weeks	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 .

Trial Locations

Locations (1)

The Manitoba Institute of Child Health; 🇨🇦 Winnipeg, Canada