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
- 24
- 试验地点
- 2
- 主要终点
- Severe hypoglycaemia (using continuous glucose monitoring)
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 Recent work (unpublished) from our lab suggests high intensity interval training (HIT) may reduce the risk of hypoglycaemia in people with type 1 diabetes, however stronger evidence is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.
详细描述
Recruitment 24 people with type 1 diabetes (T1D) will be recruited through local advertising, e.g. within the Liverpool Type 1 Diabetes (LIVT1D) Group.
Protocol The study will use a randomised counterbalanced crossover design, whereby participants will complete 3x 2-week intervention periods; control (no exercise), moderate intensity continous training (MICT) and high intensity interval training (HIT).
Intervention period Participants will complete 3x 2-week intervention periods identical in all respects except for the type of exercise completed.
The day before each intervention period participants will attend the lab at Liverpool John Moores University to have an Abbot Freestyle Libre® flash glucose monitor inserted. To access the data participants will be provide with a "Reader" in "masked" mode, ensuring the participant cannot see the data produced. The Reader will also be used to record time of exercise, insulin doses and blood glucose. Finally, participants will be provided with an activity monitor (Actigraph®) for the duration of the intervention. Participants will also be familiarised to the type of exercise being performed.
In Addition, before the first intervention period participants will also be asked to download MyFitnessPal® to record their daily food intake. An anonymous login email address and password will be given to the participant for access to this App and associated website. A 1ml finger prick blood sample will also be taken on this first visit.
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
- •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 (using continuous glucose monitoring)
时间窗: Over a 2 week intervention period
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) (using continuous glucose monitoring)(Over a 2 week intervention period)
- % of time in level 1 hyperglycaemia (10.0-13.9mmol/L) (using continuous glucose monitoring)(Over a 2 week intervention period)
- Mean glucose (using continuous glucose monitoring)(Over a 2 week intervention period)
- % of time in target range (3.9-10.0mmol/L) (using continuous glucose monitoring)(Over a 2 week intervention period)
- glycaemic variability (using continuous glucose monitoring)(2 weeks)
- % of time in level 1 hypoglycaemia (3.0-3.9mmol/L) (using continuous glucose monitoring)(Over a 2 week intervention period)
- area under the curve of episodes of hypoglycaemia and hyperglycaemia(Over a 2 week intervention period)
- % of time in level 2 hyperglycaemia (>13.9mmol/L) (using continuous glucose monitoring)(Over a 2 week intervention period)
研究者
Sam Shepherd
Lecturer/Senior Lecturer, Principle Investigator
Liverpool John Moores University