Effect of Continuous vs Intermittent Aerobic Exercise on Glycemic Control in a Barbadian Population With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Single Bout ('S')
Multiple Bout ('M')
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Adults aged 30-65 years
- Documented diagnosis of type 2 diabetes (HbA1C ≥ 6.5%)
Exclusion Criteria:
- Subjects currently managed on prandial insulin
- Subjects who have recently started insulin (within the previous month)
- Subjects with a history of frequent hypoglycemic episodes within the previous 2 weeks,
- Pregnancy
- Subjects with a history of cerebrovascular accident, myocardial infarction, chronic kidney disease, autonomic and peripheral neuropathy
- Subjects with contraindications to exercise according to ACSM 2018 guidelines
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Single Bout ('S') - 30 minutes of moderate intensity cycling
Multiple Bout ('M')
Arm Description
Subjects will perform a single 30-minute bout of moderate intensity cycling before breakfast
Subjects will perform three (3) 10-minute bouts of moderate intensity cycling before breakfast, lunch and dinner
Outcomes
Primary Outcome Measures
2 hour post prandial blood glucose level after breakfast
blood glucose level 2 hours after breakfast consumption
2 hour post prandial blood glucose level after lunch
blood glucose level 2 hours after lunch consumption
2 hour post prandial blood glucose level after dinner
blood glucose level 2 hours after dinner consumption
Fasting blood sugar level
blood sugar level after 8 hours of fasting performed on day following exercise intervention
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04006938
Brief Title
Effect of Continuous vs Intermittent Aerobic Exercise on Glycemic Control in a Barbadian Population With Type 2 Diabetes
Official Title
The Effect of Continuous Versus Intermittent Aerobic Exercise on Glycemic Control in a Barbadian Population With Type 2 Diabetes - A Crossover Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2019 (Anticipated)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Springfield College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study will be to evaluate and compare the effect of a single 30-minute bout of moderate intensity aerobic exercise to the effect of three 10-minute pre-prandial bouts of energy-matched and volume-matched aerobic exercise on 2-hr post prandial and fasting blood sugar levels, in a sample of type 2 diabetes patients, aged 30-65 years, living in Barbados
Research Hypotheses:
The three bouts of pre-prandial moderate intensity aerobic exercise will result in lower post prandial blood sugar levels when compared to the single bout of moderate intensity aerobic exercise.
The three bouts of pre-prandial moderate intensity aerobic exercise will result in lower fasting blood sugar levels on the morning following the exercise intervention when compared to the single bout of moderate intensity aerobic exercise
Detailed Description
With the background that there is increasing evidence that breaking up sedentary time with physical activity may be potentially associated with improved blood glucose levels (Francois et al., (2014) & van Dijk et al., (2013), this study aims to investigate and compare the effect of a single 30-minute bout of moderate intensity aerobic exercise to the effect of three 10-minute pre-prandial bouts of energy-matched and volume-matched aerobic exercise on 2-hr post prandial and fasting blood sugar levels in a sample of type 2 diabetes patients.
Different from previous studies, this research seeks to evaluate these effects in a Black Caribbean population, in a type 2 diabetes population on medication including insulin and also seeks to evaluate if either exercise regimen is indeed palatable to the target population by evaluating treatment acceptability.
The proposed study will be a crossover randomized controlled study. There will be two intervention groups - a single 30-minute bout of moderate intensity aerobic exercise before breakfast and three (3) 10-minute bouts of moderate intensity aerobic activity before breakfast, lunch and dinner. The primary outcome measure will be 2-hr post prandial blood sugar levels and fasting blood sugar levels on the day following the intervention. Neither subject nor investigator will be blinded to the intervention.
Subjects will include patients with a documented diagnosis of type 2 diabetes, that is a documented HbA1C ≥ 6.5%. Baseline data will include body mass and body composition and will be measured using the bioelectrical impedance technique (Tanita scale). Waist circumference will be assessed using a Gulick tape measure. Baseline sedentary behaviour and physical activity level will be assessed using the validated International Physical Activity Questionnaire.
All recruited subjects will be asked to complete two exercise interventions separated by a one-week washout period: 1) a single 30-minute bout of moderate intensity aerobic exercise before breakfast and 2) three (3) 10-minute bouts of moderate intensity aerobic activity before breakfast, lunch and dinner. Each subject will be randomized to one of two treatment sequences: single bout followed by multiple bouts (S-M) or multiple bouts followed by single bout (M-S). The randomization will be done using online statistical computing web programming (www.randomization.com) to generate a randomization schedule with balanced permutations.
Timing between exercise completion and commencement of meal intake will be approximately 15 minutes. A heart rate reserve range of 40-59% will be used to define moderate intensity. Heart rate will be measured using a validated Polar heart rate monitor. Rate of perceived exertion will be a secondary measure of exercise intensity.
Two-hour (2hr) post prandial blood sugar levels and fasting blood sugar levels on the day following the exercise intervention will be measured using a validated capillary blood glucose meter. Blood pressure will also be measured at the same times that blood glucose values are taken using a validated automated blood pressure machine.
Standardized meals of fixed nutrient content and individualized to the subject's calculated estimated daily caloric requirements will be provided to subjects on the day of the exercise interventions. Treatment acceptability will be assessed following each exercise intervention using an expert-designed questionnaire that will be piloted in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The proposed study is a crossover randomized controlled study. There will be two intervention groups - a single 30-minute bout of moderate intensity aerobic exercise before breakfast and three (3) 10-minute bouts of moderate intensity aerobic activity before breakfast, lunch and dinner.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Bout ('S') - 30 minutes of moderate intensity cycling
Arm Type
Experimental
Arm Description
Subjects will perform a single 30-minute bout of moderate intensity cycling before breakfast
Arm Title
Multiple Bout ('M')
Arm Type
Experimental
Arm Description
Subjects will perform three (3) 10-minute bouts of moderate intensity cycling before breakfast, lunch and dinner
Intervention Type
Behavioral
Intervention Name(s)
Single Bout ('S')
Intervention Description
Each subject will perform a single bout of 30-minutes of moderate-intensity cycling before breakfast
Intervention Type
Behavioral
Intervention Name(s)
Multiple Bout ('M')
Intervention Description
Each subject will perform three (3) 10-minute bouts of moderate intensity cycling before breakfast, lunch and dinner
Primary Outcome Measure Information:
Title
2 hour post prandial blood glucose level after breakfast
Description
blood glucose level 2 hours after breakfast consumption
Time Frame
single point measurement taken 2 hours after breakfast consumption
Title
2 hour post prandial blood glucose level after lunch
Description
blood glucose level 2 hours after lunch consumption
Time Frame
single point measurement taken 2 hours after lunch consumption
Title
2 hour post prandial blood glucose level after dinner
Description
blood glucose level 2 hours after dinner consumption
Time Frame
single point measurement taken 2 hours after dinner consumption
Title
Fasting blood sugar level
Description
blood sugar level after 8 hours of fasting performed on day following exercise intervention
Time Frame
single point measurement taken after 8 hours of fasting
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults aged 30-65 years
Documented diagnosis of type 2 diabetes (HbA1C ≥ 6.5%)
Exclusion Criteria:
Subjects currently managed on prandial insulin
Subjects who have recently started insulin (within the previous month)
Subjects with a history of frequent hypoglycemic episodes within the previous 2 weeks,
Pregnancy
Subjects with a history of cerebrovascular accident, myocardial infarction, chronic kidney disease, autonomic and peripheral neuropathy
Subjects with contraindications to exercise according to ACSM 2018 guidelines
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristyn C Kirton, MBBS
Phone
4133426892
Email
kkirton@springfieldcollege.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel Headley, PhD
Phone
413-748-3340
Email
sheadley@springfieldcollege.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Headley, PhD
Organizational Affiliation
Springfield College
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
24817675
Citation
Francois ME, Baldi JC, Manning PJ, Lucas SJ, Hawley JA, Williams MJ, Cotter JD. 'Exercise snacks' before meals: a novel strategy to improve glycaemic control in individuals with insulin resistance. Diabetologia. 2014 Jul;57(7):1437-45. doi: 10.1007/s00125-014-3244-6. Epub 2014 May 10.
Results Reference
background
PubMed Identifier
24041682
Citation
van Dijk JW, Venema M, van Mechelen W, Stehouwer CD, Hartgens F, van Loon LJ. Effect of moderate-intensity exercise versus activities of daily living on 24-hour blood glucose homeostasis in male patients with type 2 diabetes. Diabetes Care. 2013 Nov;36(11):3448-53. doi: 10.2337/dc12-2620. Epub 2013 Sep 16.
Results Reference
background
Citation
American College of Sports Medicine. (2018). ACSM's guidelines for exercise testing and prescription (5th edn.). Philadelphia, PA: Lippincott Williams & Wilkins.
Results Reference
background
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Effect of Continuous vs Intermittent Aerobic Exercise on Glycemic Control in a Barbadian Population With Type 2 Diabetes
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