Type 2 Diabetes MellitusNCT03626155
Does Exercise Timing Affect Glucose Levels in People With Diabetes?
A study testing Walking in people with Type 2 Diabetes Mellitus, run by University of Alberta at 1 site in Canada.
Trial summary
It is not clear if there is an optimal time for exercise to improve blood glucose profiles in people with type 2 diabetes. The goal of this study is to compare post meal and 24-hour glucose levels in 4 different conditions: i-seated control, ii-fasted state exercise, iii-30 minutes post meal exercise, and iv- 3-4-hour… Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- 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
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2018to 1 Mar 2019
- 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
- Able to understand English or French and comply with study requirements (e.g., attend visits during the day)
Who cannot join
- Contraindications to exercise (PAR-Q+, Rose Angina questionnaire, limited ability to walk for 50 min).
- Allergies or dietary restriction that could prevent adherence to standardize meals.
- Previous myocardial infarction, stroke or diagnosed coronary artery disease
- Changes in diabetes medication in last 3 months
- Treated by insulin or corticosteroids
- Change in body weight (>5%) in last 3 months
- Blood pressure >160/100 mmHg; resting heart rate>100
Trial locations and contacts
1 site in 1 country.
About this study
It is not clear if there is an optimal time for exercise to improve blood glucose profiles in people with type 2 diabetes. The goal of this study is to compare post meal and 24-hour glucose levels in 4 different conditions: i-seated control, ii-fasted state exercise, iii-30 minutes post meal exercise, and iv- 3-4-hour post meal exercise. The primary outcome of this study is glucose control assessed over 24 hours using continuous glucose monitoring.
Read the detailed description
Purpose:To compare the effects of a single bout of walking conducted at different times of the day on 24-hour glucose profiles in individuals with type 2 diabetes. In addition to a control (no exercise) conditions, a bout of walking will be completed in the following 3 conditions i. in the fasted state, before breakfast, ii. 3-4 hours after lunch, and iii. 30 minutes after dinner.
Background: Recently, we developed the Exercise-Physical Activity and Diabetes Glucose Monitoring (E-PAraDiGM), which was tested at 8 different sites across Canada (ClinicalTrials.gov Identifier: NCT02834689). The original E-PAraDiGM protocol found no significant difference in 24-hour glucose levels between the exercise and seated control condition (publication in preparation). One the of the potential reasons for this could be the timing of exercise in relation to meals. There is no clear consensus as to the optimal time for exercise for individuals with type 2 diabetes. The goal of this study is to expand on the original E-PAraDiGM study by adding fasted state exercise and 30 minute postprandial exercise to the original 2 conditions (3-4 hours after lunch and seated control).
Research Design: The complete protocol will take place over two separate 6-day periods for each participant, which includes 50 minutes of exercise done in the following 4 conditions i. in the fasted state, before breakfast, ii. 3-4hrs after lunch, iii. 30 minutes after dinner, and iv. seated control. Each participant will complete each condition according to a randomized, crossover design.
Participants: Twelve individuals with T2D will be recruited at the University of Alberta. Participants will be between the ages of 30-90 years and will have been diagnosed with T2D for more than 6 months. They will also have no contraindications to exercise, no previous myocardial infarction, strokes, or coronary artery disease. Participants will not be treated with insulin or corticosteroids and they will have had no changes in diabetes medications in the last 3 months. Furthermore, participants will have no significant changes in body weight (>5%) in the last 3 months. Their blood pressure will be below 160/100 mmHg and their resting heart rate will be below 100 beats per minute.
Baseline Assessment: An initial visit will be used to perform screening, obtain written informed consent, and collect baseline data, including: anthropometry (e.g., height, weight, waist/hip circumference), medical history (e.g., duration of diabetes, medications), exercise history (i.e., Godin Leisure Time Exercise Questionnaire), as well as HbA1c, lipids in last 6 months and Creatinine within last year. We will also measure HbA1c with a point of care device (DCA vantage) which requires a single drop of blood (similar demands as a capillary glucose measurements that people with diabetes perform routinely). Body composition with be estimated with bioelectrical impedance analysis (BIA, Tanita TBF-300A). During this initial visit, participants will also have the opportunity to practice walking on a treadmill at the speed and grade that will be assigned during the intervention period (5.0km/hr at a grade of 0.5%).
Experimental Protocol: Walking Conditions and seated control conditions. Participants will complete standardized bouts of 50 minutes of walking at ~3.5 metabolic equivalents (METs), which is equivalent to 5.0 km/h at 0.5% incline. This is chosen to represent the typical physical activity prescription for prevention and treatment of T2D and its complications (i.e., 150 minutes per week of moderate activity [3-5.9 METs] performed over 3 days of the week). A standardized 5-minute warm-up and cool-down will be included at a pace of 3.5 km/h at 0% grade. If a participant cannot comfortably complete 15 minutes of walking at this intensity in the baseline screening visit they will be allowed to reduce the speed to 4.5 km/h (3.3 METs) or 4.0 km/h (3.1 METs) and this will be recorded. Heart rate and ratings of perceived exertion will be monitored during exercise and recorded every 10 minutes. Blood pressure and capillary blood glucose will be monitored before and after exercise. Participants will complete this walking protocol in the fasted state, 3-4 hours post lunch, and 30 minutes post dinner. In the seated control condition, participants will sit quietly and be allowed to read, work on a computer and/or watch a video for 60 minutes to match the time spent walking in the alternate intervention. At the beginning and end of each walking and sedentary control condition, participants will be ask to expire into a mouth piece connected to a metabolic cart for the measurement of oxygen consumption and carbon dioxide production. With guidance from the study coordinator, participants will also perform a 24 hour recall of the foods they consumed on the previous day.
Standardized Diet: Participants will be provided with all their food (breakfast, lunch, dinner, and snacks) for two days in each condition. Macronutrient profile will be based on Diabetes Canada guidelines with meal/snack providing ~55% carbohydrate (focusing on low glycemic index), ~30% fat, and ~15% protein. Participants will be provided with a food log with prescribed timing for each meal and will be asked to complete this log to confirm compliance and record any deviations with the diet.
Summary of laboratory visits:
- Day 1. Participants will arrive to PADL at their designated appointment time and an individual will insert both the Medtronic and Freestyle Libre CGM. They will be given standardized meals at this visit which will be consumed on days 2 and 3.
- Day 2. Participants will arrive at PADL for the first of the 4 conditions. The randomization process will determine which of the conditions will be completed and the state (fasted or fed) that the participant will come in.
- Day 3. Standardized meals (breakfast, lunch, and dinner) will be consumed on day 3. There is no lab visit on day 3.
- Day 4. As a wash out day, participants will resume their typical daily activities and eating habits which will be recorded in their log books.
- Day 5. Participants will complete condition 2 on this day. Standardized meals will be consumed.
- Day 6. Standardized meals (breakfast, lunch, and dinner) will be consumed on day 6. There is no lab visit on day 3.
- Day 7.The Medtronic CGM will be taken out and replaced with another Medtronic device (Note: the Medtronic CGM lasts for 6 days while the newer Abbott CGM lasts for 14 days). Standardized meals will be consumed on this day.
- Day 8. Condition 3 will be completed on this day. Standardized meals will be consumed.
- Day 9. No lab visit this day. Standardized meals will be consumed.
- Day 10. As a wash out day, participants will resume their typical daily activities and eating habits which will be recorded in their log books.
- Day 11. Participants will complete condition 4 on this day. Standardized meals will be consumed.
- Day 12. Standardized meals (breakfast, lunch, and dinner) will be consumed on day 6 and then the CGMs will be removed.
Analyses. Data from both CGMs will be compared between the 24-hour periods which follow each intervention. Parameters of interest include post meal area under the glucose curve, mean glucose, glycemic variability, fasting glucose, time spent in hyperglycemia (>10mmol/l), and time spent in hypoglycemia (<4mmol/l). A one-way Anova will be used to compare the 4 conditions.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Walking, Seated Control
- Keywords
- Walking, type 2 diabetes, continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkingBehavioural
Walking will last 50 minutes and will be at 5.0 km/h and at 0.5% incline
Seated ControlBehavioural
Participants will be asked to sit quietly and read during a 50 minute control period
| Study group | Role | What they receive |
|---|---|---|
| Seated Control | Experimental | Not described Receives: Behavioral: Seated Control |
| Morning Exercise (walking) | Experimental | Not described Receives: Behavioral: Walking |
| Afternoon Exercise (walking) | Experimental | Not described Receives: Behavioral: Walking |
| Evening Exercise (walking) | Experimental | Not described Receives: Behavioral: Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean 24-hour glucose
Glucose measured by continuous glucose monitoring over 24 hours starting at the beginning of exercise on seated control
Measured: Within the 24 hours following exercise or control
Secondary outcomes (5)
Postprandial glucose
The mean of the 2-hour glucose concentrations following breakfast, lunch and dinner
Measured: Within the 24 hours following exercise or control
Glucose variability
Calculated as the mean amplitude of glycemic excursion (i.e. MAGE)
Measured: Within the 24 hours following exercise or control
Fasting glucose
The mean of 3 consecutive continuous glucose monitoring values before breakfast
Measured: Within the 24 hours following exercise or control
Energy expenditure (METs)
This outcome is assessed by the metabolic cart during exercise
Measured: Within the 50 minutes of exercise or control
Respiratory Exchange Ratio (RER)
This outcome is assessed by the metabolic cart during exercise
Measured: Within the 50 minutes of exercise or control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start1 Jun 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Normand Boule, University of Alberta
- Investigators
- Normand Boule, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626155
- Sponsor's protocol ID
- Pro00078578
- Status last verified
- Sep 2019
- First submitted
- 9 Jul 2018
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Exercise Timing Affect Glucose Levels in People With Diabetes?
- ClinicalTrials.gov ID
- NCT03626155
- Acronym / sponsor ID
- Pro00078578
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Walking, type 2 diabetes, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 10 Aug 2018 (actual)
- 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.
It is not clear if there is an optimal time for exercise to improve blood glucose profiles in people with type 2 diabetes. The goal of this study is to compare post meal and 24-hour glucose levels in 4 different conditions: i-seated control, ii-fasted state exercise, iii-30 minutes post meal exercise, and iv- 3-4-hour post meal exercise. The primary outcome of this study is glucose control assessed over 24 hours using continuous glucose monitoring.
Detailed description
Purpose:To compare the effects of a single bout of walking conducted at different times of the day on 24-hour glucose profiles in individuals with type 2 diabetes. In addition to a control (no exercise) conditions, a bout of walking will be completed in the following 3 conditions i. in the fasted state, before breakfast, ii. 3-4 hours after lunch, and iii. 30 minutes after dinner.
Background: Recently, we developed the Exercise-Physical Activity and Diabetes Glucose Monitoring (E-PAraDiGM), which was tested at 8 different sites across Canada (ClinicalTrials.gov Identifier: NCT02834689). The original E-PAraDiGM protocol found no significant difference in 24-hour glucose levels between the exercise and seated control condition (publication in preparation). One the of the potential reasons for this could be the timing of exercise in relation to meals. There is no clear consensus as to the optimal time for exercise for individuals with type 2 diabetes. The goal of this study is to expand on the original E-PAraDiGM study by adding fasted state exercise and 30 minute postprandial exercise to the original 2 conditions (3-4 hours after lunch and seated control).
Research Design: The complete protocol will take place over two separate 6-day periods for each participant, which includes 50 minutes of exercise done in the following 4 conditions i. in the fasted state, before breakfast, ii. 3-4hrs after lunch, iii. 30 minutes after dinner, and iv. seated control. Each participant will complete each condition according to a randomized, crossover design.
Participants: Twelve individuals with T2D will be recruited at the University of Alberta. Participants will be between the ages of 30-90 years and will have been diagnosed with T2D for more than 6 months. They will also have no contraindications to exercise, no previous myocardial infarction, strokes, or coronary artery disease. Participants will not be treated with insulin or corticosteroids and they will have had no changes in diabetes medications in the last 3 months. Furthermore, participants will have no significant changes in body weight (>5%) in the last 3 months. Their blood pressure will be below 160/100 mmHg and their resting heart rate will be below 100 beats per minute.
Baseline Assessment: An initial visit will be used to perform screening, obtain written informed consent, and collect baseline data, including: anthropometry (e.g., height, weight, waist/hip circumference), medical history (e.g., duration of diabetes, medications), exercise history (i.e., Godin Leisure Time Exercise Questionnaire), as well as HbA1c, lipids in last 6 months and Creatinine within last year. We will also measure HbA1c with a point of care device (DCA vantage) which requires a single drop of blood (similar demands as a capillary glucose measurements that people with diabetes perform routinely). Body composition with be estimated with bioelectrical impedance analysis (BIA, Tanita TBF-300A). During this initial visit, participants will also have the opportunity to practice walking on a treadmill at the speed and grade that will be assigned during the intervention period (5.0km/hr at a grade of 0.5%).
Experimental Protocol: Walking Conditions and seated control conditions. Participants will complete standardized bouts of 50 minutes of walking at ~3.5 metabolic equivalents (METs), which is equivalent to 5.0 km/h at 0.5% incline. This is chosen to represent the typical physical activity prescription for prevention and treatment of T2D and its complications (i.e., 150 minutes per week of moderate activity [3-5.9 METs] performed over 3 days of the week). A standardized 5-minute warm-up and cool-down will be included at a pace of 3.5 km/h at 0% grade. If a participant cannot comfortably complete 15 minutes of walking at this intensity in the baseline screening visit they will be allowed to reduce the speed to 4.5 km/h (3.3 METs) or 4.0 km/h (3.1 METs) and this will be recorded. Heart rate and ratings of perceived exertion will be monitored during exercise and recorded every 10 minutes. Blood pressure and capillary blood glucose will be monitored before and after exercise. Participants will complete this walking protocol in the fasted state, 3-4 hours post lunch, and 30 minutes post dinner. In the seated control condition, participants will sit quietly and be allowed to read, work on a computer and/or watch a video for 60 minutes to match the time spent walking in the alternate intervention. At the beginning and end of each walking and sedentary control condition, participants will be ask to expire into a mouth piece connected to a metabolic cart for the measurement of oxygen consumption and carbon dioxide production. With guidance from the study coordinator, participants will also perform a 24 hour recall of the foods they consumed on the previous day.
Standardized Diet: Participants will be provided with all their food (breakfast, lunch, dinner, and snacks) for two days in each condition. Macronutrient profile will be based on Diabetes Canada guidelines with meal/snack providing ~55% carbohydrate (focusing on low glycemic index), ~30% fat, and ~15% protein. Participants will be provided with a food log with prescribed timing for each meal and will be asked to complete this log to confirm compliance and record any deviations with the diet.
Summary of laboratory visits:
- Day 1. Participants will arrive to PADL at their designated appointment time and an individual will insert both the Medtronic and Freestyle Libre CGM. They will be given standardized meals at this visit which will be consumed on days 2 and 3.
- Day 2. Participants will arrive at PADL for the first of the 4 conditions. The randomization process will determine which of the conditions will be completed and the state (fasted or fed) that the participant will come in.
- Day 3. Standardized meals (breakfast, lunch, and dinner) will be consumed on day 3. There is no lab visit on day 3.
- Day 4. As a wash out day, participants will resume their typical daily activities and eating habits which will be recorded in their log books.
- Day 5. Participants will complete condition 2 on this day. Standardized meals will be consumed.
- Day 6. Standardized meals (breakfast, lunch, and dinner) will be consumed on day 6. There is no lab visit on day 3.
- Day 7.The Medtronic CGM will be taken out and replaced with another Medtronic device (Note: the Medtronic CGM lasts for 6 days while the newer Abbott CGM lasts for 14 days). Standardized meals will be consumed on this day.
- Day 8. Condition 3 will be completed on this day. Standardized meals will be consumed.
- Day 9. No lab visit this day. Standardized meals will be consumed.
- Day 10. As a wash out day, participants will resume their typical daily activities and eating habits which will be recorded in their log books.
- Day 11. Participants will complete condition 4 on this day. Standardized meals will be consumed.
- Day 12. Standardized meals (breakfast, lunch, and dinner) will be consumed on day 6 and then the CGMs will be removed.
Analyses. Data from both CGMs will be compared between the 24-hour periods which follow each intervention. Parameters of interest include post meal area under the glucose curve, mean glucose, glycemic variability, fasting glucose, time spent in hyperglycemia (>10mmol/l), and time spent in hypoglycemia (<4mmol/l). A one-way Anova will be used to compare the 4 conditions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Seated Control | Experimental | Behavioral: Seated Control |
| Morning Exercise (walking) | Experimental | Behavioral: Walking |
| Afternoon Exercise (walking) | Experimental | Behavioral: Walking |
| Evening Exercise (walking) | Experimental | Behavioral: Walking |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with T2D for more than 6 months
- 30-90 years of age
- Able to understand English or French and comply with study requirements (e.g., attend visits during the day)
Key exclusion criteria (7 listed)
- Contraindications to exercise (PAR-Q+, Rose Angina questionnaire, limited ability to walk for 50 min).
- Allergies or dietary restriction that could prevent adherence to standardize meals.
- Previous myocardial infarction, stroke or diagnosed coronary artery disease
- Changes in diabetes medication in last 3 months
- Treated by insulin or corticosteroids
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 will last 50 minutes and will be at 5.0 km/h and at 0.5% incline | Behavioural | Afternoon Exercise (walking), Evening Exercise (walking), Morning Exercise (walking) |
| Seated ControlParticipants will be asked to sit quietly and read during a 50 minute control period | Behavioural | Seated Control |
Primary outcome
Mean 24-hour glucose
Time frame: Within the 24 hours following exercise or control
Glucose measured by continuous glucose monitoring over 24 hours starting at the beginning of exercise on seated control
5 secondary outcomes
Postprandial glucose
Time frame: Within the 24 hours following exercise or control
Glucose variability
Time frame: Within the 24 hours following exercise or control
Fasting glucose
Time frame: Within the 24 hours following exercise or control
Energy expenditure (METs)
Time frame: Within the 50 minutes of exercise or control
Respiratory Exchange Ratio (RER)
Time frame: Within the 50 minutes of exercise or 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 26 Sep 2019.
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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.
Normand Boule, PhD principal investigator
University of Alberta
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 Type 2 Diabetes Mellitus, run by University of Alberta 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 3 inclusion and 7 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 26 Sep 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 (time frame: Within the 24 hours following exercise or control). 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 26 Sep 2019.