The Effect of Continuous Versus Intermittent Aerobic Exercise on Glycemic Control in a Barbadian Population With Type 2 Diabetes - A Crossover Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Fasting blood sugar level
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 30-65 years
- •Documented diagnosis of type 2 diabetes (HbA1C ≥ 6.5%)
排除标准
- •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
研究组 & 干预措施
Single Bout ('S') - 30 minutes of moderate intensity cycling
Subjects will perform a single 30-minute bout of moderate intensity cycling before breakfast
干预措施: Single Bout ('S') (Behavioral)
Multiple Bout ('M')
Subjects will perform three (3) 10-minute bouts of moderate intensity cycling before breakfast, lunch and dinner
干预措施: Multiple Bout ('M') (Behavioral)
结局指标
主要结局
Fasting blood sugar level
时间窗: single point measurement taken after 8 hours of fasting
blood sugar level after 8 hours of fasting performed on day following exercise intervention
2 hour post prandial blood glucose level after dinner
时间窗: single point measurement taken 2 hours after dinner consumption
blood glucose level 2 hours after dinner consumption
2 hour post prandial blood glucose level after breakfast
时间窗: single point measurement taken 2 hours after breakfast consumption
blood glucose level 2 hours after breakfast consumption
2 hour post prandial blood glucose level after lunch
时间窗: single point measurement taken 2 hours after lunch consumption
blood glucose level 2 hours after lunch consumption
次要结局
未报告次要终点
研究者
Kristyn Kirton
Principal Investigator
Springfield College
