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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
Springfield College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 29, 2019
    Last Updated
    July 1, 2019
    Sponsor
    Springfield College
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    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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