Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of Sedentary Behaviour on Metabolic Parameters

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by University of British Columbia
Information provided by (Responsible Party):
University of British Columbia Identifier:
First received: March 13, 2014
Last updated: January 13, 2015
Last verified: January 2015

The rates of sedentary activity are increasing. Studies have shown that time spent on doing sedentary activities is an independent risk factor for cardiovascular disease. Prior studies have shown that interrupting inactivity improved the body's handling of blood glucose and gene expression. The investigators plan to explore this further by examining the effects of interrupting 4 hours of inactivity with 2 minutes of moderate intensity exercise every 20 minutes on the following metabolic parameters: blood pressure, cortisol, C-Reactive Protein, glucose and insulin levels.

Condition Intervention
Sedentary Lifestyle
Type 2 Diabetes
Other: Inactivity
Other: Activity

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Sedentary Behaviour on Metabolic Parameters

Resource links provided by NLM:

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: every 60 minutes for 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • C Reactive Protein [ Time Frame: every 60 minutes for 4 hours ] [ Designated as safety issue: No ]
  • Insulin Levels [ Time Frame: every 60 minutes for 4 hours ] [ Designated as safety issue: No ]
  • Blood glucose levels [ Time Frame: every 60 minutes for 4 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2015
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
During a 4 hour Meal Test subjects will cycle for 2 minutes every 20 minutes
Other: Activity
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.
During a 4 hour Meal Test study subjects will remain inactive (remain lying on a bed)
Other: Inactivity
Subjects will remain inactive (lying on a bed) for 4 hours.

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.


Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02088827

Contact: Gale Tedder, RN, BSN 604-875-5115

Canada, British Columbia
Gerontology Research Lab Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Gale Tedder, RN, BSN    604-875-5115   
Principal Investigator: Kenneth M Madden, MSc, MD         
Sub-Investigator: Marisa Wan, MD         
Sponsors and Collaborators
University of British Columbia
Principal Investigator: Kenneth M Madden, MSc, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia Identifier: NCT02088827     History of Changes
Other Study ID Numbers: H13-01886
Study First Received: March 13, 2014
Last Updated: January 13, 2015
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Sedentary Behaviour
Type 2 Diabetes
Older Adults

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases processed this record on February 27, 2015