Does Exercise Timing Affect Glucose Levels in People With Diabetes?

Does Exercise Timing Affect Glucose Levels in People With Diabetes?



Sponsors

Lead Sponsor



Source

University of Alberta

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No

Is Us Export

No


Brief 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 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.

Overall Status

Recruiting

Start Date

2018-06-01

Completion Date

2020-01-01

Primary Completion Date

2019-06-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Mean 24-hour glucose
Within the 24 hours following exercise or control

Secondary Outcome

Measure

Time Frame

Postprandial glucose
Within the 24 hours following exercise or control
Glucose variability
Within the 24 hours following exercise or control
Fasting glucose
Within the 24 hours following exercise or control
Energy expenditure (METs)
Within the 50 minutes of exercise or control
Respiratory Exchange Ratio (RER)
Within the 50 minutes of exercise or control

Enrollment

12

Condition


Intervention

Intervention Type

Behavioral

Intervention Name


Description

Walking will last 50 minutes and will be at 5.0 km/h and at 0.5% incline

Arm Group Label

Morning Exercise (walking)

Afternoon Exercise (walking)

Evening Exercise (walking)



Intervention Type

Behavioral

Intervention Name


Description

Participants will be asked to sit quietly and read during a 50 minute control period

Arm Group Label

Seated Control



Eligibility

Criteria

Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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

Gender

All

Minimum Age

30 Years

Maximum Age

90 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Normand Boule, PhD
Principal Investigator
University of Alberta

Overall Contact

Last Name

Normand Boule, PhD

Phone

7804924695

Email



Location

Facility

Status

Contact

University of Alberta
Edmonton Alberta T6G 2E1 Canada
Recruiting
Last Name: Normand Boule, PhD
Phone: 7804924695
Email: [email protected]

Location Countries

Country

Canada


Verification Date

2018-08-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

University of Alberta

Investigator Full Name

Normand Boule

Investigator Title

Professor


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

4

Arm Group

Arm Group Label

Seated Control

Arm Group Type

Experimental


Arm Group Label

Morning Exercise (walking)

Arm Group Type

Experimental


Arm Group Label

Afternoon Exercise (walking)

Arm Group Type

Experimental


Arm Group Label

Evening Exercise (walking)

Arm Group Type

Experimental



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Matthew Munan, BSc

Phone

7804928079

Email



Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Crossover Assignment

Primary Purpose

Supportive Care

Masking

None (Open Label)


Study First Submitted

July 9, 2018

Study First Submitted Qc

August 7, 2018

Study First Posted

August 10, 2018

Last Update Submitted

August 7, 2018

Last Update Submitted Qc

August 7, 2018

Last Update Posted

August 10, 2018


ClinicalTrials.gov processed this data on August 10, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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