CClinicalTrials.gg
Status unknownNCT04006938Updated Jul 5, 2019

Effect of Continuous vs Intermittent Aerobic Exercise on Glycemic Control in a Barbadian Population With Type 2 Diabetes

An interventional study of Single Bout ('S') and Multiple Bout ('M') in Diabetes Mellitus, Type 2, sponsored by Springfield College. Status unknown. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Springfield College · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 30 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Springfield College is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults aged 30-65 years
  • Documented diagnosis of type 2 diabetes (HbA1C ≥ 6.5%)

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Single Bout ('S') - 30 minutes of moderate intensity cycling

    Subjects will perform a single 30-minute bout of moderate intensity cycling before breakfast

    Behavioral: Single Bout ('S')

  • Experimental
    Multiple Bout ('M')

    Subjects will perform three (3) 10-minute bouts of moderate intensity cycling before breakfast, lunch and dinner

    Behavioral: Multiple Bout ('M')

Interventions

  • BehavioralSingle Bout ('S')

    Each subject will perform a single bout of 30-minutes of moderate-intensity cycling before breakfast

  • BehavioralMultiple Bout ('M')

    Each subject will perform three (3) 10-minute bouts of moderate intensity cycling before breakfast, lunch and dinner

06

What researchers measure

Primary outcomes

  1. 2 hour post prandial blood glucose level after breakfast

    blood glucose level 2 hours after breakfast consumption

    Time frame: single point measurement taken 2 hours after breakfast consumption

  2. 2 hour post prandial blood glucose level after lunch

    blood glucose level 2 hours after lunch consumption

    Time frame: single point measurement taken 2 hours after lunch consumption

  3. 2 hour post prandial blood glucose level after dinner

    blood glucose level 2 hours after dinner consumption

    Time frame: single point measurement taken 2 hours after dinner consumption

  4. Fasting blood sugar level

    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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 24817675 ↗
  • 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. PubMed 24041682 ↗
  • American College of Sports Medicine. (2018). ACSM's guidelines for exercise testing and prescription (5th edn.). Philadelphia, PA: Lippincott Williams & Wilkins.
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04006938
Lead sponsor
Springfield College
Responsible party
Kristyn Kirton (Principal Investigator, Springfield College) — Principal investigator
First posted
Jul 5, 2019
Start date
Jul 2019 (estimated)
Primary completion
Feb 2020 (estimated)
Completion
Apr 2020 (estimated)
Last update
Jul 5, 2019

Study contacts

Kristyn C Kirton, MBBS
Contact
kkirton@springfieldcollege.edu
4133426892
Samuel Headley, PhD
Contact
sheadley@springfieldcollege.edu
413-748-3340
Samuel Headley, PhD
study chair · Springfield College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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