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Does Exercise Timing Affect Glucose Levels in People With Diabetes?

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ClinicalTrials.gov Identifier: NCT03626155
Recruitment Status : Completed
First Posted : August 10, 2018
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Normand Boule, University of Alberta

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: Walking Behavioral: Seated Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Does Exercise Timing Affect Glucose Levels in People With Diabetes?
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Seated Control Behavioral: Seated Control
Participants will be asked to sit quietly and read during a 50 minute control period

Experimental: Morning Exercise (walking) Behavioral: Walking
Walking will last 50 minutes and will be at 5.0 km/h and at 0.5% incline

Experimental: Afternoon Exercise (walking) Behavioral: Walking
Walking will last 50 minutes and will be at 5.0 km/h and at 0.5% incline

Experimental: Evening Exercise (walking) Behavioral: Walking
Walking will last 50 minutes and will be at 5.0 km/h and at 0.5% incline




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Postprandial glucose [ Time Frame: Within the 24 hours following exercise or control ]
    The mean of the 2-hour glucose concentrations following breakfast, lunch and dinner

  2. Glucose variability [ Time Frame: Within the 24 hours following exercise or control ]
    Calculated as the mean amplitude of glycemic excursion (i.e. MAGE)

  3. Fasting glucose [ Time Frame: Within the 24 hours following exercise or control ]
    The mean of 3 consecutive continuous glucose monitoring values before breakfast

  4. Energy expenditure (METs) [ Time Frame: Within the 50 minutes of exercise or control ]
    This outcome is assessed by the metabolic cart during exercise

  5. Respiratory Exchange Ratio (RER) [ Time Frame: Within the 50 minutes of exercise or control ]
    This outcome is assessed by the metabolic cart during exercise



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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626155


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Normand Boule, PhD University of Alberta
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Responsible Party: Normand Boule, Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT03626155    
Other Study ID Numbers: Pro00078578
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Normand Boule, University of Alberta:
Walking
type 2 diabetes
continuous glucose monitoring
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases