Type 2 Diabetes MellitusPhase 4POWERNCT00755547
A Study of the Effects of Exercise Intensity on Insulin Sensitivity in Overweight Youth
A Phase 4 study testing Aerobic Exercise Training in people with Type 2 Diabetes Mellitus and Adolescent Obesity, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Adolescent Obesity
- What is being tested?
- Aerobic Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2008to Jan 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity for Overweight Youth at Risk for Type 2 Diabetes Mellitus (POWER) Trial
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.
Read more
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus, Adolescent Obesity
- Being tested
- Aerobic Exercise Training
- Keywords
- Childhood, insulin sensitivity, steatosis, spectroscopy
- Medical subject headings
- Diabetes Mellitus, Type 2, Pediatric Obesity, Insulin Resistance, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity | Experimental | 70-85% of peak oxygen uptake for 30 min 3-5 days/week. Receives: Other: Aerobic Exercise Training |
| Low Intensity | Experimental | 40-55% of peak oxygen uptake for 60 min 3-5 days/week Receives: Other: Aerobic Exercise Training |
| Sedentary Control | No intervention | Regular activities of daily living for 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity measured from Bergman's frequently sampled intravenous glucose tolerance test
Measured: 6 months
Secondary outcomes (1)
1H-Magnetic resonance spectroscopy-derived measure of lipid content in liver and muscle tissue
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Institute of Child Health
- Responsible party
- Principal investigator, Jon McGavock, University of Manitoba
- Investigators
- Jonathan M McGavock, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755547
- Sponsor's protocol ID
- SC-5-08-2489-JM
- Other IDs
- GRT2008-10
- Acronym
- POWER
- Status last verified
- Mar 2013
- First submitted
- 18 Sep 2008
- Last updated
- 29 Mar 2013
- Results posted
- No
Publications
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.
PubMed 33544653Mollard 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.
PubMed 24522441
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity for Overweight Youth at Risk for Type 2 Diabetes Mellitus (POWER) Trial
- ClinicalTrials.gov ID
- NCT00755547
- Acronym / sponsor ID
- POWER / SC-5-08-2489-JM
- Conditions
- Type 2 Diabetes Mellitus, Adolescent Obesity
- Keywords
- Childhood, insulin sensitivity, steatosis, spectroscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Institute of Child Health
- Study start
- Apr 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 19 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Intensity | Experimental | Other: Aerobic Exercise Training70-85% of peak oxygen uptake for 30 min 3-5 days/week. |
| Low Intensity | Experimental | Other: Aerobic Exercise Training40-55% of peak oxygen uptake for 60 min 3-5 days/week |
| Sedentary Control | No intervention | –Regular activities of daily living for 6 months |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise TrainingAll 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. | Other | High Intensity, Low Intensity |
Primary outcome
Insulin sensitivity measured from Bergman's frequently sampled intravenous glucose tolerance test
Time frame: 6 months
1 secondary outcome
1H-Magnetic resonance spectroscopy-derived measure of lipid content in liver and muscle tissue
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
- Derived from this study: PubMed 33544653Hrubeniuk 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.
- Derived from this study: PubMed 24522441Mollard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan M McGavock, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aerobic Exercise Training in people with Type 2 Diabetes Mellitus and Adolescent Obesity, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity measured from Bergman's frequently sampled intravenous glucose tolerance test (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00755547, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2013.