- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02088827
Effects of Sedentary Behaviour on Metabolic Parameters
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There is a current trend towards increasing time spent in sedentary behaviour. More jobs are being automated, and more time is spent in front of a computer, playing video games and watching television.Current studies suggest that sedentary behaviour is an independent risk factor for cardiovascular disease. Increasing time spent in sedentary behaviour has been linked to all-cause mortality, markers of cardiovascular disease and metabolic syndrome. However, the data is mainly from cross-sectional studies and based on self-recall, limiting the ability to draw definitive conclusions.
Current exercise guidelines recommend at least 150 minutes of moderate to vigorous intensity exercise per week. It may be difficult for some elderly people to meet these guidelines. Older adults with diabetes are already at a higher risk fo conditions that are affected by sedentary behaviour and may stand to benefit the most from intervention.
This study proposes to study the effects of breaking up sedentary activity with moderate intensity exercise on multiple metabolic parameters in older adults with diabetes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Gerontology Research Lab
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 65 years of age or older
- type 2 diabetes managed with diet or oral hypoglycemic agents
Exclusion Criteria:
- using insulin to manage diabetes
- baseline of pre-session blood glucose reading equal to or greater than 10 mmol/L
- any medical condition that would limit the ability to perform activity portion of the study
- people not comfortable exercising on a stationary bicycle
- subject answers yes to one of more of the questions in the Physical Activity Readiness Questionnaire
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Activity
During a 4 hour Meal Test subjects will cycle for 2 minutes every 20 minutes
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Subjects will spend 4 hours of inactivity (lying on a bed) broken up by 2 minutes of moderate intensity biking (on a stationary bike) every 20 minutes.
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Other: Inactivity
During a 4 hour Meal Test study subjects will remain inactive (remain lying on a bed)
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Subjects will remain inactive (lying on a bed) for 4 hours.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood Pressure
Time Frame: every 60 minutes for 4 hours
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every 60 minutes for 4 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
C Reactive Protein
Time Frame: every 60 minutes for 4 hours
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every 60 minutes for 4 hours
|
|
Insulin Levels
Time Frame: every 60 minutes for 4 hours
|
every 60 minutes for 4 hours
|
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Blood glucose levels
Time Frame: every 60 minutes for 4 hours
|
every 60 minutes for 4 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kenneth M Madden, MSc, MD, University of British Columbia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H13-01886
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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