Effects of Sedentary Behaviour on Metabolic Parameters

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT02088827
First received: March 13, 2014
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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: July 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Activity
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.
Inactivity
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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT02088827

Contacts
Contact: Gale Tedder, RN, BSN 604-875-5115 gale.tedder@vch.ca
Contact: Chris Lockhart, BSc. 604-875-4111 ext 68535 chris.lockhart@vch.ca

Locations
Canada, British Columbia
Gerontology Research Lab Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Gale Tedder, RN, BSN    604-875-5115    gale.tedder@telus.net   
Contact: Chris Lockhart, BSc.    604-875-4111 ext 68535    chris.lockhart@vch.ca   
Principal Investigator: Kenneth M Madden, MSc, MD         
Sub-Investigator: Marisa Wan, MD         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Kenneth M Madden, MSc, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02088827     History of Changes
Other Study ID Numbers: H13-01886
Study First Received: March 13, 2014
Last Updated: July 16, 2014
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014