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Effects of Sedentary Behaviour on Metabolic Parameters

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ClinicalTrials.gov Identifier: NCT02088827
Recruitment Status : Recruiting
First Posted : March 17, 2014
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Kenneth Madden, University of British Columbia

Brief Summary:
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 or disease Intervention/treatment
Sedentary Lifestyle Type 2 Diabetes Other: Inactivity Other: Activity

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Sedentary Behaviour on Metabolic Parameters
Actual Study Start Date : January 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



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

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


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

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: Boris Feldman 604-875-5115 boris.feldman@vch.ca

Locations
Canada, British Columbia
Gerontology Research Lab Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Boris Feldman    604-875-5115    boris.feldman@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

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 Posted: March 17, 2014    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
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