Sedentary LifestyleNCT02088827
Effects of Sedentary Behaviour on Metabolic Parameters
A study testing Inactivity and Activity in people with Sedentary Lifestyle and Type 2 Diabetes, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sedentary Lifestyle, Type 2 Diabetes
- What is being tested?
- Inactivity and Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2015to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years of age or older
- type 2 diabetes managed with diet or oral hypoglycemic agents
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sedentary Lifestyle, Type 2 Diabetes
- Being tested
- Inactivity, Activity
- Keywords
- Exercise, Sedentary Behaviour, Type 2 Diabetes, Older Adults
- Medical subject headings
- Sedentary Behavior, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InactivityOther
Subjects will remain inactive (lying on a bed) for 4 hours.
ActivityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Activity | Other | During a 4 hour Meal Test subjects will cycle for 2 minutes every 20 minutes Receives: Other: Activity |
| Inactivity | Other | During a 4 hour Meal Test study subjects will remain inactive (remain lying on a bed) Receives: Other: Inactivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Measured: every 60 minutes for 4 hours
Secondary outcomes (3)
C Reactive Protein
Measured: every 60 minutes for 4 hours
Insulin Levels
Measured: every 60 minutes for 4 hours
Blood glucose levels
Measured: every 60 minutes for 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study start1 Jan 2015
- Primary completion12 May 2020
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Madden, University of British Columbia
- Investigators
- Kenneth M Madden, MSc, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088827
- Sponsor's protocol ID
- H13-01886
- Status last verified
- Oct 2022
- First submitted
- 13 Mar 2014
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sedentary Behaviour on Metabolic Parameters
- ClinicalTrials.gov ID
- NCT02088827
- Acronym / sponsor ID
- H13-01886
- Conditions
- Sedentary Lifestyle, Type 2 Diabetes
- Keywords
- Exercise, Sedentary Behaviour, Type 2 Diabetes, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activity | Other | Other: ActivityDuring a 4 hour Meal Test subjects will cycle for 2 minutes every 20 minutes |
| Inactivity | Other | Other: InactivityDuring a 4 hour Meal Test study subjects will remain inactive (remain lying on a bed) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 65 years of age or older
- type 2 diabetes managed with diet or oral hypoglycemic agents
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InactivitySubjects will remain inactive (lying on a bed) for 4 hours. | Other | Inactivity |
| ActivitySubjects 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. | Other | Activity |
Primary outcome
Blood Pressure
Time frame: every 60 minutes for 4 hours
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth M Madden, MSc, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inactivity and Activity in people with Sedentary Lifestyle and Type 2 Diabetes, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: every 60 minutes for 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.