WalkingE-PAraDiGMNCT02834689
The Canadian E-PAraDiGM (Exercise Physical Activity and Diabetes Glucose Monitoring) Protocol
A study testing Walking in people with Walking and Seated Control, run by University of British Columbia at 1 site in Canada.
Trial summary
Walking is encouraged for people with type 2 diabetes but there is little evidence that performing a bout of walking can improve glucose control. Furthermore, it is unknown how participant characteristics (e.g., age, sex, medications) impact the acute glucose responses to walking in people with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Walking, Seated Control
- What is being tested?
- Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2016to 1 Dec 2017
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with T2D for more than 6 months
- 30-90 years of age
- No contra-indications to exercise (PAR-Q+, Rose Angina questionnaire, limited ability to walk for 50 min).
- No previous myocardial infarction, stroke or diagnosed coronary artery disease
- No changes in diabetes medication in last 3 months
- Not treated by insulin or corticosteroids
Show all 11Show fewer
- No significant change in body weight (>5%) in last 3 months
- Blood pressure <160/100 mmHg; resting HR<100
- Able to understand English or French and comply with study requirements (e.g., attend visits during the day)
- Hemoglobin A1C <9.0%
- No prior history of hypoglycaemia during activity or sleep
Who cannot join
- Chest pain during physical activity.
- Chest pain while resting (no physical activity) in the past month.
- Loss of balance or consciousness because of dizziness in past 12 months
- Bone or joint problem (for example, back, knee, or hip) that could be made worse by a change in physical activity.
- Currently pregnant or planning on becoming pregnant in the next 3 months
- Currently taking exogenous insulin
- Previous heart attack or stroke
- Any other reason that prevents ability to walk on a treadmill for 50 minutes
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia, Okanagan.
Kelowna, British Columbia, V1V 1V7
About this study
Walking is encouraged for people with type 2 diabetes but there is little evidence that performing a bout of walking can improve glucose control. Furthermore, it is unknown how participant characteristics (e.g., age, sex, medications) impact the acute glucose responses to walking in people with type 2 diabetes. The primary purpose of this study is to examine how a standardized bout of walking impacts glucose control assessed over 24 hours using continuous glucose monitoring. A secondary purpose is to determine whether responses are influenced by age, sex, and medication use.
- Conditions
- Walking, Seated Control
- Being tested
- Walking, Seated Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkingBehavioural
Walking on a treadmill at 3.5 METS for 50 minutes
Seated ControlBehavioural
Sitting for 50 minutes
| Study group | Role | What they receive |
|---|---|---|
| Walking | Experimental | Walking on a treadmill at 3.5 metabolic equivalents (METS) for 50 minutes Receives: Behavioral: Walking |
| Seated Control | Experimental | Sitting for 50 minutes Receives: Behavioral: Seated Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean 24 hour glucose levels (mmol/l)
Mean glucose assessed for 24 hours after walking or seated control assessed by continuous glucose monitoring
Measured: 24 hours
Secondary outcomes (6)
Mean amplitude of glycemic excursions (MAGE)
MAGE assessed for 24 hours after walking or seated control assessed by continuous glucose monitoring
Measured: 24 hours
Standard Deviation of Glucose Values
Standard deviation of glucose values assessed for 24 hours after walking or seated control assessed by continuous glucose monitoring
Measured: 24 hours
Post-dinner glucose control
Incremental area under the glucose curve for 2 hours following dinner
Measured: 2 hours following dinner
Post-lunch glucose control
Incremental area under the glucose curve for 2 hours following lunch
Measured: 2 hours following lunch
Post-breakfast glucose control
Incremental area under the glucose curve for 2 hours following breakfast
Measured: 2 hour following breakfast
Time spent above 10 mmol/l glucose
Time in minutes above 10 mmol/l assessed by continuous glucose monitoring over 24 hours
Measured: 24 hours following walking or seated control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study start1 Jul 2016
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WalkingStudies 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta, University of Calgary, McMaster University, Université de Sherbrooke, Centre de Recheche du Centre Hospitalier Université Laval, Children's Hospital Research Institute of Manitoba, Medtronic
- Responsible party
- Principal investigator, Jonathan Little, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834689
- Sponsor's protocol ID
- H1600377
- Acronym
- E-PAraDiGM
- Status last verified
- Oct 2019
- First submitted
- 13 Jul 2016
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Rees JL, Chang CR, Francois ME, Marcotte-Chenard A, Fontvieille A, Klaprat ND, Dyck RA, Funk DR, Snydmiller G, Bastell K, Godkin FE, Dube MC, Riesco E, McGavock JM, Yardley JE, Sigal RJ, Gibala MJ, Weisnagel SJ, Prado CM, Jung M, Manders R, Lee T, Singer J, Boule NG, Little JP. Minimal effect of walking before dinner on glycemic responses in type 2 diabetes: outcomes from the multi-site E-PAraDiGM study. Acta Diabetol. 2019 Jul;56(7):755-765. doi: 10.1007/s00592-019-01358-x. Epub 2019 May 15.
PubMed 31093764
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Canadian E-PAraDiGM (Exercise Physical Activity and Diabetes Glucose Monitoring) Protocol
- ClinicalTrials.gov ID
- NCT02834689
- Acronym / sponsor ID
- E-PAraDiGM / H1600377
- Conditions
- Walking, Seated Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- University of Alberta, University of Calgary, McMaster University, Université de Sherbrooke, Centre de Recheche du Centre Hospitalier Université Laval, Children's Hospital Research Institute of Manitoba, Medtronic
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 15 Jul 2016 (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.
Walking is encouraged for people with type 2 diabetes but there is little evidence that performing a bout of walking can improve glucose control. Furthermore, it is unknown how participant characteristics (e.g., age, sex, medications) impact the acute glucose responses to walking in people with type 2 diabetes. The primary purpose of this study is to examine how a standardized bout of walking impacts glucose control assessed over 24 hours using continuous glucose monitoring. A secondary purpose is to determine whether responses are influenced by age, sex, and medication use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walking | Experimental | Behavioral: WalkingWalking on a treadmill at 3.5 metabolic equivalents (METS) for 50 minutes |
| Seated Control | Experimental | Behavioral: Seated ControlSitting for 50 minutes |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosed with T2D for more than 6 months
- 30-90 years of age
- No contra-indications to exercise (PAR-Q+, Rose Angina questionnaire, limited ability to walk for 50 min).
- No previous myocardial infarction, stroke or diagnosed coronary artery disease
- No changes in diabetes medication in last 3 months
Key exclusion criteria (8 listed)
- Chest pain during physical activity.
- Chest pain while resting (no physical activity) in the past month.
- Loss of balance or consciousness because of dizziness in past 12 months
- Bone or joint problem (for example, back, knee, or hip) that could be made worse by a change in physical activity.
- Currently pregnant or planning on becoming pregnant in the next 3 months
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 |
|---|---|---|
| WalkingWalking on a treadmill at 3.5 METS for 50 minutes | Behavioural | Walking |
| Seated ControlSitting for 50 minutes | Behavioural | Seated Control |
Primary outcome
Mean 24 hour glucose levels (mmol/l)
Time frame: 24 hours
Mean glucose assessed for 24 hours after walking or seated control assessed by continuous glucose monitoring
6 secondary outcomes
Mean amplitude of glycemic excursions (MAGE)
Time frame: 24 hours
Standard Deviation of Glucose Values
Time frame: 24 hours
Post-dinner glucose control
Time frame: 2 hours following dinner
Post-lunch glucose control
Time frame: 2 hours following lunch
Post-breakfast glucose control
Time frame: 2 hour following breakfast
Time spent above 10 mmol/l glucose
Time frame: 24 hours following walking or seated control
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 3 Oct 2019.
- Derived from this study: PubMed 31093764Rees JL, Chang CR, Francois ME, Marcotte-Chenard A, Fontvieille A, Klaprat ND, Dyck RA, Funk DR, Snydmiller G, Bastell K, Godkin FE, Dube MC, Riesco E, McGavock JM, Yardley JE, Sigal RJ, Gibala MJ, Weisnagel SJ, Prado CM, Jung M, Manders R, Lee T, Singer J, Boule NG, Little JP. Minimal effect of walking before dinner on glycemic responses in type 2 diabetes: outcomes from the multi-site E-PAraDiGM study. Acta Diabetol. 2019 Jul;56(7):755-765. doi: 10.1007/s00592-019-01358-x. Epub 2019 May 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking in people with Walking and Seated Control, 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 11 inclusion and 8 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 3 Oct 2019. 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?
Mean 24 hour glucose levels (mmol/l) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02834689, which also lists 1 linked publication.
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 3 Oct 2019.