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Effects of Sedentary Behaviour on Metabolic Parameters

This study is currently recruiting participants.
Verified April 2017 by Kenneth Madden, University of British Columbia
Sponsor:
ClinicalTrials.gov Identifier:
NCT02088827
First Posted: March 17, 2014
Last Update Posted: April 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Kenneth Madden, University of British Columbia
  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: None (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 Kenneth Madden, University of British Columbia:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: every 60 minutes for 4 hours ]

Secondary Outcome Measures:
  • C Reactive Protein [ Time Frame: every 60 minutes for 4 hours ]
  • Insulin Levels [ Time Frame: every 60 minutes for 4 hours ]
  • Blood glucose levels [ Time Frame: every 60 minutes for 4 hours ]

Estimated Enrollment: 20
Actual Study Start Date: January 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088827


Contacts
Contact: Gale Tedder, RN, BSN 604-875-5115 gale.tedder@vch.ca

Locations
Canada, British Columbia
Gerontology Research Lab Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Gale Tedder, RN, BSN    604-875-5115    gale.tedder@telus.net   
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

Responsible Party: Kenneth Madden, Head, VGH Division of Geriatric Medicine, University of British Columbia
ClinicalTrials.gov Identifier: NCT02088827     History of Changes
Other Study ID Numbers: H13-01886
First Submitted: March 13, 2014
First Posted: March 17, 2014
Last Update Posted: April 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kenneth Madden, 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