EXIT: Prospective Study of the Response to Exercise

Type 2 Diabetes Clinical Trial

— EXIT  

Official title:

Exercise and Irisin Trial (EXIT): Prospective Cohort Study of the Determinants of the Metabolic Response to Exercise in Obese Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02204670
• Other study ID #: B2014:064
• Status: Recruiting
• Phase: N/A
• First received: July 28, 2014
• Last updated: March 18, 2015
• Start date: July 2014

Study information

• Verified date: March 2015
• Source: University of Manitoba
• Contact: Martin Sénéchal, Ph.D.
• Email: MSenechal[@]mich.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Fat
• Type 2 Diabetes

Intervention

Other:
• Acute 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.

Locations

Country	Name	City	State
Canada	The Manitoba Institute of Child Health	Winnipeg

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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 .	6 weeks	No