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

Primary Purpose

Type 2 Diabetes Mellitus, Adolescent Obesity

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Aerobic Exercise Training
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring Childhood, insulin sensitivity, steatosis, spectroscopy

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Manitoba Institute of Child Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

High Intensity

Low Intensity

Sedentary Control

Arm Description

70-85% of peak oxygen uptake for 30 min 3-5 days/week.

40-55% of peak oxygen uptake for 60 min 3-5 days/week

Regular activities of daily living for 6 months

Outcomes

Primary Outcome Measures

Insulin sensitivity measured from Bergman's frequently sampled intravenous glucose tolerance test

Secondary Outcome Measures

1H-Magnetic resonance spectroscopy-derived measure of lipid content in liver and muscle tissue

Full Information

First Posted
September 18, 2008
Last Updated
March 27, 2013
Sponsor
University of Manitoba
Collaborators
Manitoba Institute of Child Health
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1. Study Identification

Unique Protocol Identification Number
NCT00755547
Brief Title
A Study of the Effects of Exercise Intensity on Insulin Sensitivity in Overweight Youth
Acronym
POWER
Official Title
Physical Activity for Overweight Youth at Risk for Type 2 Diabetes Mellitus (POWER) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Manitoba Institute of Child Health

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Adolescent Obesity
Keywords
Childhood, insulin sensitivity, steatosis, spectroscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Intensity
Arm Type
Experimental
Arm Description
70-85% of peak oxygen uptake for 30 min 3-5 days/week.
Arm Title
Low Intensity
Arm Type
Experimental
Arm Description
40-55% of peak oxygen uptake for 60 min 3-5 days/week
Arm Title
Sedentary Control
Arm Type
No Intervention
Arm Description
Regular activities of daily living for 6 months
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insulin sensitivity measured from Bergman's frequently sampled intravenous glucose tolerance test
Time Frame
6 months
Secondary Outcome Measure Information:
Title
1H-Magnetic resonance spectroscopy-derived measure of lipid content in liver and muscle tissue
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan M McGavock, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manitoba Institute of Child Health
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E3P4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33544653
Citation
Hrubeniuk TJ, Hay JL, MacIntosh AC, Wicklow B, Wittmeier K, McGavock JM, Senechal M. Interindividual variation in cardiometabolic health outcomes following 6 months of endurance training in youth at risk of type 2 diabetes mellitus. Appl Physiol Nutr Metab. 2021 Jul;46(7):727-734. doi: 10.1139/apnm-2020-0707. Epub 2021 Feb 5.
Results Reference
derived
PubMed Identifier
24522441
Citation
Mollard RC, Senechal M, MacIntosh AC, Hay J, Wicklow BA, Wittmeier KD, Sellers EA, Dean HJ, Ryner L, Berard L, McGavock JM. Dietary determinants of hepatic steatosis and visceral adiposity in overweight and obese youth at risk of type 2 diabetes. Am J Clin Nutr. 2014 Apr;99(4):804-12. doi: 10.3945/ajcn.113.079277. Epub 2014 Feb 12.
Results Reference
derived

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

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