A Study of the Effects of Exercise Intensity on Insulin Sensitivity in Overweight Youth

Type 2 Diabetes Mellitus Clinical Trial

— POWER  

Official title:

Physical Activity for Overweight Youth at Risk for Type 2 Diabetes Mellitus (POWER) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755547
• Other study ID #: SC-5-08-2489-JM
• Secondary ID: GRT2008-10
• Status: Completed
• Phase: Phase 4
• First received: September 18, 2008
• Last updated: March 27, 2013
• Start date: April 2008
• Est. completion date: January 2013

Study information

• Verified date: March 2013
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial Summary

Background:

The investigators know that exercise helps children develop strong bones and muscles and generally stay healthy. What is unclear however, is how much exercise a child needs to lower their risk of developing type 2 diabetes.

Objective:

The investigators will try to find out whether high-intensity exercise for a short-period of time is better than moderately intense exercise for improving the diabetes risk profile in teens who are at risk for type 2 diabetes.

The working hypothesis is that exercise-mediated improvements in insulin sensitivity (a risk factor for diabetes) will be greater following vigorous intermittent physical activity than following low intensity physical activity in overweight adolescents 13-18 yrs at risk for T2DM.

Brief Description of Research Project: Teenagers between the ages of 13 and 18 yrs, who are at risk for type 2 diabetes (either by their family history or an abnormal response to sugar) will be randomly assigned to one of two activity groups or a control group. The activity groups will have supervised exercise sessions 3 to 5 days per week for 6 months. One group will do high-intensity exercise, and the other will do lower-intensity exercise. We will measure how sensitive their body is to insulin and the amount of fat in their muscle and liver tissue at the beginning and end of the exercise intervention.

Description:

The Physical activity for OverWEight youth at Risk for type 2 diabetes (POWER) Trial is a randomized controlled clinical trial designed to study the effects of aerobic exercise training regimens differing in intensity (relative to peak fitness) on insulin sensitivity in overweight youth. Additionally, this trial will explore the biologic mechanisms through which chronic physical activity alters lipid metabolism to result in improvements in insulin sensitivity.

We will recruit 90 eligible adolescents and randomly assign them to one of two six-month intervention arms that differ by intensity but elicit similar amounts of energy expenditure: (1) a low intensity continuous activity arm (40-55% of peak oxygen uptake for 60 min); (2) vigorous intensity intermittent activity arm (70-85% of peak oxygen uptake for 30 min) or a sedentary control group. The primary outcome measure of this trial will be insulin sensitivity, measured directly from Bergman's frequently sampled intravenous glucose tolerance test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 19 Years

Eligibility

Inclusion criteria:

• Ethnic minority considered at risk for T2DM

• In utero exposure to hyperglycemia (i.e. mother with gestational or frank diabetes during pregnancy) and/or evidence of hepatic steatosis (serum ALT > 60U/L, ultrasound or MRI-based evidence of steatosis).

Exclusion criteria:

• The investigators will exclude any patients that may have altered insulin sensitivity or tissue lipid content that would confound (mask) the effects of the intervention.

• These include overweight adolescents who:

• are diagnosed with impaired glucose tolerance or type 2 diabetes

• are currently being treated with corticosteroids or atypical antipsychotics, as these agents significantly influence carbohydrate metabolism

• are undergoing puberty (Tanner Stage 2-4) at the time of the investigation, as it is associated with transient changes in insulin sensitivity

• have an orthopaedic injury that would prevent them from performing the intervention

• have experienced weight loss or enrolled in weight loss program in the six months prior to the study

• have a history of alcoholism or drug abuse.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adolescent Obesity
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Pediatric Obesity
• Type 2 Diabetes Mellitus

Intervention

Other:
• Aerobic Exercise Training
All sessions will be designed to elicit a certain degree of energy expenditure that will progressively increase throughout the trial. Adolescents randomized to the vigorous activity group will perform interval sessions that ensure an average heart rate between 70 and 85% of maximal heart rate reserve while those randomized will perform aerobic activity between 40 and 50% of heart rate reserve. The goal for the trial will be to expend a minimum of 350 kcal. The type of exercise will depend on the preference of each participant however, during the supervised sessions walking/jogging on a treadmill or outdoors will be used to elicit exercise intensities. The three activity sessions held at the YMCA-YWCA facilities in Winnipeg and be supervised by a trained kinesiologist who will record heart rate and perceived exertion for each session.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Manitoba Institute of Child Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity measured from Bergman's frequently sampled intravenous glucose tolerance test		6 months	No
Secondary	1H-Magnetic resonance spectroscopy-derived measure of lipid content in liver and muscle tissue		6 months	No