Diabetes Mellitus, Type 2 Clinical Trial
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
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
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.
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