Can High Intensity Interval Training Reduce Fear of Hypoglycaemia and Improve Glycaemic Control in People With Type 1 Diabetes?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Severe hypoglycaemia
研究概览
简要总结
There is clear evidence that regular exercise improves wellbeing and reduces the risk of diabetes related complications in people with type 1 diabetes. However, many people with type 1 diabetes do not exercise regularly. The primary reason for this is fear of hypoglycaemia and loss of glycaemic control associated with exercise. This loss of glycaemic control is associated with traditional moderate intensity continous aerobic exercise advocated in the guidelines for exercise in people with type 1 diabetes. Recent work (unpublished) from our lab suggests high intensity interval training (HIT) may reduce the risk of hypoglycaemia in people with type 1 diabetes, however stronger evidence is needed before firm conclusions can be drawn.
Therefore, the aim of this study is to determine the effects of HIT on glycaemic control in people with type 1 diabetes compared to no exercise and traditional moderate intensity continous exercise.
24 people with type 1 diabetes will be recruited to complete a randomised counterbalanced cross over study comparing 3x 2-week interventions periods. During these intervention periods participant will maintain their habitual lifestyle but complete either no exercise (control), traditional moderate intensity continous exercise or high intensity interval training. Throughout the intervention periods participants glycaemic control will be monitored using a flash glucose monitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •T1D diagnosis more than 6 months ago (to ensure participants are out of the honeymoon period),
- •Using a basal bolus insulin regime or insulin pump therapy
- •BMI ≤ 32 kg.m-2
排除标准
- •Pregnancy (or planning pregnancy)
- •Disability preventing participation in an exercise regime
- •Autonomic neuropathy
- •Medication that affects heart rate (this will affect estimation of fitness)
- •Major surgery planned within 6 weeks of study
- •Uncontrolled blood pressure
- •Significant history of hyperglycaemia
- •History of severe hypoglycaemia requiring third party assistance within the last 3 months
- •Severe non-proliferative and unstable proliferative retinopathy
结局指标
主要结局
Severe hypoglycaemia
时间窗: 2 weeks
Number of severe hypoglycaemic events (\<3mmol/l) during the 2 week intervention period
次要结局
- % of time in level 2 hypoglycaemia (<3.0mmol/L)(2 weeks)
- % of time in level 2 hyperglycaemia (>13.9mmol/L)(2 weeks)
- Mean glucose(2 weeks)
- % of time in level 1 hypoglycaemia (3.0-3.9mmol/L)(2 weeks)
- % of time in target range (3.9-10.0mmol/L)(2 weeks)
- % of time in level 1 hyperglycaemia (10.0-13.9mmol/L)(2 weeks)
- glycaemic variability (coefficient of variation and Standard Deviation)(2 weeks)
- area under the curve of episodes of hypoglycaemia and hyperglycaemia(2 weeks)