Diabetes Mellitus, Type 2NCT03730727
Exercise-meal Timing and Postprandial Glucose Control
A study testing Physical activity and Meal in people with Diabetes Mellitus, Type 2 and Hyperglycemia, Postprandial, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
Physical activity helps maintain optimal postprandial blood glucose control. However, there is a lack of clear information regarding the optimal meal-activity timing required to maximize blood glucose control. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hyperglycemia, Postprandial, Physical Activity
- What is being tested?
- Physical activity and Meal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Oct 2017to 8 Dec 2018
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years.
- Body Mass Index 18-30 kg/m2.
- Generally healthy.
Who cannot join
- Smoking.
- Pregnancy, or planning to become pregnant, or a nursing mother.
- More than 2 kg weight change during the last month.
- Diabetes.
- Evidence of, or being treated for, cancer or infectious/non-infectious chronic hematological, pulmonary, cardiac, hepatic, renal, or gastrointestinal diseases.
- Any contraindication to exercise
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Birmingham
Edgbaston, West Midlands, B15 2TT
About this study
Official title: Maximizing Postprandial Glycaemic Control: When is the Right Time for Physical Activity
Physical activity helps maintain optimal postprandial blood glucose control. However, there is a lack of clear information regarding the optimal meal-activity timing required to maximize blood glucose control. By using continuous glucose monitoring (CGM), this randomized controlled trial will determine whether implementing a bout of physical activity immediately before, or immediately after, or shortly after a meal is most optimal. This study will also independently examine the effects of three different physical activities: walking, standing, and circuit-exercises. Minimizing the changes in blood glucose following a meal not only reduces the risk of type 2 diabetes but also reduces cardiovascular-related mortality. Therefore, the data produced by this project will have very important implications for informing healthcare policy and physical activity recommendations.
Read the detailed description
Healthy volunteers will undergo an informed consent and screening visit to determine their eligibility. Participants who are included will then be assigned to one of the three studies (walking, standing, or circuit-exercises) and then come to the lab on 5 consecutive mornings to undergo a pre-trial visit and 4 experimental trial visits (A, B, C, and D). The order of the experimental trial visits will be randomized in a counter-balanced, cross-over design.
Screening visit: Having read the participant info sheet, a study investigator will discuss the project with the potential participant who will have the chance to ask any questions. Informed consent will be sought and a General Health and Physical Activity Questionnaire will be completed. Body weight, height, resting heart rate, blood pressure, and waist circumference will be measured, and blood measures of glycated hemoglobin, triglycerides, and cholesterol will be taken.
Pre-trials visit: Participants will come to the laboratory to receive an accelerometer physical activity monitor, a continuous glucose monitor, and to complete a physical activity bout (walking, standing, or stair climbing, depending on which study they are enrolled). Over the next 5 consecutive days, participants will be instructed to maintain their normal diet and activity habits, to record their dietary intake, to refrain from vigorous exercise and alcohol, and continue wearing the accelerometer and continuous glucose monitoring devices at all times.
Experimental trial A: Following an 8-10 hour overnight fast, participants will come to the lab and will be given a 500 calorie meal-replacement drink to consume within 10 minutes. They will remain in a seated position for 2 hours and then complete the physical activity bout (30-min walk, 30-min stand, or 10-min circuit-exercises) after which they may leave the lab. Resting and post-activity heart rate and blood pressure will be recorded.
Experimental trial B: Following an 8-10 hour overnight fast, participants will come to the lab and complete the physical activity bout. Immediately after this they will be given a 500 calorie meal-replacement drink to consume within 10 minutes and will remain in a seated position for 2 hours, after which they may leave the lab. Resting and post-activity heart rate and blood pressure will be recorded.
Experimental trial C: Following an 8-10 hour overnight fast, participants will come to the lab and will be given a 500 calorie meal-replacement drink to consume within 10 minutes. Immediately after finishing the meal they will complete the physical activity bout and then remain in a seated position until 2-hours has passed since ingesting the meal. After this time they may leave the lab. Resting and post-activity heart rate and blood pressure will be recorded.
Experimental trial D: Following an 8-10 hour overnight fast, participants will come to the lab and will be given a 500 calorie meal-replacement drink to consume within 10 minutes. Thirty minutes after finishing the meal they will complete the physical activity bout and then remain in a seated position until 2-hours has passed since ingesting the meal. After this time they may leave the lab. Resting and post-activity heart rate and blood pressure will be recorded.
After the final trial, the accelerometer and continuous glucose monitoring devices will be collected and the participant's role in the study will end.
- Conditions
- Diabetes Mellitus, Type 2, Hyperglycemia, Postprandial, Physical Activity, Glucose Intolerance
- Being tested
- Physical activity, Meal
- Keywords
- Exercise, Type 2 diabetes, Walking, Standing, Circuit exercises, Inactivity, Blood glucose control, Continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia, Motor Activity, Glucose Intolerance, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
Physical activity will consist of either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises (10 squats, 10 push-ups, 10 lunges, 10 sit-ups).
MealDietary supplement
Liquid meal replacement shake containing 500 kcal, with 55% kcals from carb, 30% from fat, and 15% from protein.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | A liquid meal replacement shake containing 500 kcal (55% kcals from carb, 30% fat, 15% protein) will be administered at approx. 8 am following an 8-10 hour overnight fast. Postprandial blood glucose responses will be assessed for 2-hours post-ingestion. Two-hours after ingestion of the meal, participants will complete a bout of physical activity (either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises [10 squats, 10 push-ups, 10 lunges, 10 sit-ups]). Receives: Behavioral: Physical activity; Dietary Supplement: Meal |
| Immediate prior to meal | Experimental | At approx. 8 am following an 8-10 hour overnight fast, participants will complete a bout of physical activity (either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises [10 squats, 10 push-ups, 10 lunges, 10 sit-ups]). Immediately after completion of this bout, a liquid meal replacement shake containing 500 kcal will be administered. Postprandial blood glucose responses will be assessed for 2-hours post-ingestion. Receives: Behavioral: Physical activity; Dietary Supplement: Meal |
| Immediate post-meal | Experimental | A liquid meal replacement shake containing 500 kcal will be administered at approx. 8 am following an 8-10 hour overnight fast. Postprandial blood glucose responses will be assessed for 2-hours post-ingestion. Immediately after ingestion of the meal, participants will complete a bout of physical activity (either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises [10 squats, 10 push-ups, 10 lunges, 10 sit-ups]). Receives: Behavioral: Physical activity; Dietary Supplement: Meal |
| 30-minutes post-meal | Experimental | A liquid meal replacement shake containing 500 kcal will be administered at approx. 8 am following an 8-10 hour overnight fast. Postprandial blood glucose responses will be assessed for 2-hours post-ingestion. Thirty-minutes after ingestion of the meal, participants will complete a bout of physical activity (either 30-mins of standing still, 30-mins of walking at a self selected brisk pace on a treadmill, or 3-sets of circuit-exercises [10 squats, 10 push-ups, 10 lunges, 10 sit-ups]). Receives: Behavioral: Physical activity; Dietary Supplement: Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial blood glucose concentrations.
Continuous glucose monitoring (CGM; Dexcom G5 Mobile) will be used to measure the change in glucose levels from baseline.
Measured: In all trials, postprandial blood glucose concentrations will be measured - the change from baseline (immediately prior to meal ingestion) 2-hours after meal ingestion.
Secondary outcomes (3)
Postprandial blood glucose control (mean).
Mean glucose levels will be derived from CGM-measurements.
Measured: In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).
Postprandial blood glucose control (standard deviation).
The standard deviation of glucose levels will be derived from CGM-measurements.
Measured: In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).
Postprandial blood glucose control.
The mean amplitude of glycemic excursions will be derived from CGM-measurements.
Measured: In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start9 Oct 2017
- Primary completion9 Nov 2018
- Study completion8 Dec 2018
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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Three independent groups of participants will enter 1 of 3 studies, each of which involves a randomised, crossover, controlled trial containing 4 trials: (i) control, meal ingestion no activity; (ii) activity bout immediately prior to meal; (iii) activity bout immediately after ingestion of meal; (iv) activity bout 30-mins after ingestion of meal.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730727
- Sponsor's protocol ID
- ERN_18-0942
- Status last verified
- Dec 2018
- First submitted
- 31 Oct 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Solomon TPJ, Tarry E, Hudson CO, Fitt AI, Laye MJ. Immediate post-breakfast physical activity improves interstitial postprandial glycemia: a comparison of different activity-meal timings. Pflugers Arch. 2020 Feb;472(2):271-280. doi: 10.1007/s00424-019-02300-4. Epub 2019 Aug 8.
PubMed 31396757
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing Postprandial Glycaemic Control: When is the Right Time for Physical Activity
- ClinicalTrials.gov ID
- NCT03730727
- Acronym / sponsor ID
- ERN_18-0942
- Conditions
- Diabetes Mellitus, Type 2, Hyperglycemia, Postprandial, Physical Activity, Glucose Intolerance
- Keywords
- Exercise, Type 2 diabetes, Walking, Standing, Circuit exercises, Inactivity, Blood glucose control, Continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 9 Nov 2018 (actual)
- Study completion
- 8 Dec 2018 (actual)
- First posted
- 5 Nov 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.
Physical activity helps maintain optimal postprandial blood glucose control. However, there is a lack of clear information regarding the optimal meal-activity timing required to maximize blood glucose control. By using continuous glucose monitoring (CGM), this randomized controlled trial will determine whether implementing a bout of physical activity immediately before, or immediately after, or shortly after a meal is most optimal. This study will also independently examine the effects of three different physical activities: walking, standing, and circuit-exercises. Minimizing the changes in blood glucose following a meal not only reduces the risk of type 2 diabetes but also reduces cardiovascular-related mortality. Therefore, the data produced by this project will have very important implications for informing healthcare policy and physical activity recommendations.
Detailed description
Healthy volunteers will undergo an informed consent and screening visit to determine their eligibility. Participants who are included will then be assigned to one of the three studies (walking, standing, or circuit-exercises) and then come to the lab on 5 consecutive mornings to undergo a pre-trial visit and 4 experimental trial visits (A, B, C, and D). The order of the experimental trial visits will be randomized in a counter-balanced, cross-over design.
Screening visit: Having read the participant info sheet, a study investigator will discuss the project with the potential participant who will have the chance to ask any questions. Informed consent will be sought and a General Health and Physical Activity Questionnaire will be completed. Body weight, height, resting heart rate, blood pressure, and waist circumference will be measured, and blood measures of glycated hemoglobin, triglycerides, and cholesterol will be taken.
Pre-trials visit: Participants will come to the laboratory to receive an accelerometer physical activity monitor, a continuous glucose monitor, and to complete a physical activity bout (walking, standing, or stair climbing, depending on which study they are enrolled). Over the next 5 consecutive days, participants will be instructed to maintain their normal diet and activity habits, to record their dietary intake, to refrain from vigorous exercise and alcohol, and continue wearing the accelerometer and continuous glucose monitoring devices at all times.
Experimental trial A: Following an 8-10 hour overnight fast, participants will come to the lab and will be given a 500 calorie meal-replacement drink to consume within 10 minutes. They will remain in a seated position for 2 hours and then complete the physical activity bout (30-min walk, 30-min stand, or 10-min circuit-exercises) after which they may leave the lab. Resting and post-activity heart rate and blood pressure will be recorded.
Experimental trial B: Following an 8-10 hour overnight fast, participants will come to the lab and complete the physical activity bout. Immediately after this they will be given a 500 calorie meal-replacement drink to consume within 10 minutes and will remain in a seated position for 2 hours, after which they may leave the lab. Resting and post-activity heart rate and blood pressure will be recorded.
Experimental trial C: Following an 8-10 hour overnight fast, participants will come to the lab and will be given a 500 calorie meal-replacement drink to consume within 10 minutes. Immediately after finishing the meal they will complete the physical activity bout and then remain in a seated position until 2-hours has passed since ingesting the meal. After this time they may leave the lab. Resting and post-activity heart rate and blood pressure will be recorded.
Experimental trial D: Following an 8-10 hour overnight fast, participants will come to the lab and will be given a 500 calorie meal-replacement drink to consume within 10 minutes. Thirty minutes after finishing the meal they will complete the physical activity bout and then remain in a seated position until 2-hours has passed since ingesting the meal. After this time they may leave the lab. Resting and post-activity heart rate and blood pressure will be recorded.
After the final trial, the accelerometer and continuous glucose monitoring devices will be collected and the participant's role in the study will end.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Three independent groups of participants will enter 1 of 3 studies, each of which involves a randomised, crossover, controlled trial containing 4 trials: (i) control, meal ingestion no activity; (ii) activity bout immediately prior to meal; (iii) activity bout immediately after ingestion of meal; (iv) activity bout 30-mins after ingestion of meal.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Physical activity, Dietary Supplement: MealA liquid meal replacement shake containing 500 kcal (55% kcals from carb, 30% fat, 15% protein) will be administered at approx. 8 am following an 8-10 hour overnight fast. Postprandial blood glucose responses will be assessed for 2-hours post-ingestion. Two-hours after ingestion of the meal, participants will complete a bout of physical activity (either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises [10 squats, 10 push-ups, 10 lunges, 10 sit-ups]). |
| Immediate prior to meal | Experimental | Behavioral: Physical activity, Dietary Supplement: MealAt approx. 8 am following an 8-10 hour overnight fast, participants will complete a bout of physical activity (either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises [10 squats, 10 push-ups, 10 lunges, 10 sit-ups]). Immediately after completion of this bout, a liquid meal replacement shake containing 500 kcal will be administered. Postprandial blood glucose responses will be assessed for 2-hours post-ingestion. |
| Immediate post-meal | Experimental | Behavioral: Physical activity, Dietary Supplement: MealA liquid meal replacement shake containing 500 kcal will be administered at approx. 8 am following an 8-10 hour overnight fast. Postprandial blood glucose responses will be assessed for 2-hours post-ingestion. Immediately after ingestion of the meal, participants will complete a bout of physical activity (either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises [10 squats, 10 push-ups, 10 lunges, 10 sit-ups]). |
| 30-minutes post-meal | Experimental | Behavioral: Physical activity, Dietary Supplement: MealA liquid meal replacement shake containing 500 kcal will be administered at approx. 8 am following an 8-10 hour overnight fast. Postprandial blood glucose responses will be assessed for 2-hours post-ingestion. Thirty-minutes after ingestion of the meal, participants will complete a bout of physical activity (either 30-mins of standing still, 30-mins of walking at a self selected brisk pace on a treadmill, or 3-sets of circuit-exercises [10 squats, 10 push-ups, 10 lunges, 10 sit-ups]). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years.
- Body Mass Index 18-30 kg/m2.
- Generally healthy.
Key exclusion criteria (6 listed)
- Smoking.
- Pregnancy, or planning to become pregnant, or a nursing mother.
- More than 2 kg weight change during the last month.
- Diabetes.
- Evidence of, or being treated for, cancer or infectious/non-infectious chronic hematological, pulmonary, cardiac, hepatic, renal, or gastrointestinal diseases.
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 |
|---|---|---|
| Physical activityPhysical activity will consist of either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises (10 squats, 10 push-ups, 10 lunges, 10 sit-ups). | Behavioural | 30-minutes post-meal, Control, Immediate post-meal, Immediate prior to meal |
| MealLiquid meal replacement shake containing 500 kcal, with 55% kcals from carb, 30% from fat, and 15% from protein. | Dietary supplement | 30-minutes post-meal, Control, Immediate post-meal, Immediate prior to meal |
Primary outcome
Postprandial blood glucose concentrations.
Time frame: In all trials, postprandial blood glucose concentrations will be measured - the change from baseline (immediately prior to meal ingestion) 2-hours after meal ingestion.
Continuous glucose monitoring (CGM; Dexcom G5 Mobile) will be used to measure the change in glucose levels from baseline.
3 secondary outcomes
Postprandial blood glucose control (mean).
Time frame: In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).
Postprandial blood glucose control (standard deviation).
Time frame: In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).
Postprandial blood glucose control.
Time frame: In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).
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 11 Dec 2018.
- Derived from this study: PubMed 31396757Solomon TPJ, Tarry E, Hudson CO, Fitt AI, Laye MJ. Immediate post-breakfast physical activity improves interstitial postprandial glycemia: a comparison of different activity-meal timings. Pflugers Arch. 2020 Feb;472(2):271-280. doi: 10.1007/s00424-019-02300-4. Epub 2019 Aug 8.
- Individual participant dataSharing planned: Undecided
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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 Physical activity and Meal in people with Diabetes Mellitus, Type 2 and Hyperglycemia, Postprandial, run by University of Birmingham at 1 site in United Kingdom.
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 6 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 11 Dec 2018. 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 United Kingdom. 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?
Postprandial blood glucose concentrations. (time frame: In all trials, postprandial blood glucose concentrations will be measured - the change from baseline (immediately prior to meal ingestion) 2-hours after meal ingestion.). 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 NCT03730727, 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 11 Dec 2018; AzTrials last refreshed its copy on 27 Oct 2026.