Diabetes Mellitus, Type 2 Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05666479 -
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
|
||
Completed |
NCT05647083 -
The Effect of Massage on Diabetic Parameters
|
N/A | |
Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
Completed |
NCT02836704 -
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
|
Phase 4 | |
Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
Completed |
NCT04562714 -
Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
|
N/A | |
Completed |
NCT02009488 -
Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
Completed |
NCT05896319 -
Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
|
N/A | |
Recruiting |
NCT05598203 -
Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes
|
N/A | |
Completed |
NCT05046873 -
A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
|
Phase 1 | |
Terminated |
NCT04090242 -
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
|
N/A | |
Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
Completed |
NCT03620357 -
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
|
N/A | |
Completed |
NCT03604224 -
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
|
||
Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
Completed |
NCT03620890 -
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
|
Phase 4 | |
Withdrawn |
NCT05473286 -
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
|
||
Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
Completed |
NCT04531631 -
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes
|
Phase 2 |