此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

HIT on Hypoglycaemic Risk in T1D

2021年9月10日 更新者:Sam Shepherd、Liverpool John Moores University

Can High Intensity Interval Training Reduce Fear of Hypoglycaemia and Improve Glycaemic Control in People With Type 1 Diabetes?

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 Recent work (unpublished) from our lab suggests high intensity interval training (HIT) may reduce the risk of hypoglycaemia in people with type 1 diabetes, however stronger evidence is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.

研究概览

详细说明

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.

Participants will then complete the 2-week intervention period. During this period participants will be asked to maintain their habitual lifestyle, but only complete the exercise prescribed by the research team (HIT or MICT), or no exercise during the control intervention. Participants will be asked to exercise on day 1, 3, 6, 8, 10 and 13 of the intervention period. Exercise will be completed at any time, but must not be performed following an overnight fast. Participants will be asked to record their blood glucose immediately before and after exercise and 2h post exercise using a finger stick blood sample and automated glucose reader. If participants need to take additional carbohydrates to adjust blood glucose following exercise the investigators will also ask for this to be recorded (what was consumed and time after exercise) using a note in the MyFitnessPal app. Participants will record all insulin doses, time of exercise and food intake for the duration of the intervention period.

Training MICT: Participants will be asked to complete 30 minutes of continuous exercise. Participants will be able to choose any form of exercise (e.g. running or cycling) as long as it is continous in nature. During exercise participants will be asked to maintain a heart rate between 60-70% of their predicted maximum (220-age).

HIT: Participants will be provided with a training guide containing information on the exercises. The programme involves repeated 1 minute bouts of simple on the spot movements interspersed with 1 minute of rest. During the intervals participants will be advised to reach a heart rate of approx. 80% of their predicted maximum heart rate (220-age). The 1 minute interval will be split between 2 consecutive 30 second exercises. The research team have a library of 18 exercises, with 9 suggested exercise pairs. Participants will be advised to complete 6 intervals during each session.

Participants will complete training in a place of their choosing. If requested participants will be able to train in the labs at LJMU.

Participants will be given a polar H7/10 Bluetooth heart rate monitor. Participants will be advised to wear this monitor during all training sessions. The monitor will provide a measure of training intensity and compliance with the suggested heart rate and training programme.

Participants will be asked to download the App PolarBeat to their smartphone. This App will be used to monitor heart rate during the training sessions. In addition, participants will be given a login email address and password for PolarFlow (www.polar.flow.com), a cloud storage site run by Polar for the storage and analysis of heart rate data. All heart rate data measured during training sessions will be uploaded to Polar Flow. This will allow the research team to investigate training intensity achieved during all sessions.

Safety Subjects will be asked to check their blood glucose level to ensure it is safe to exercise. The investigators will use the guidelines that are currently used in a national study of exercise for patients with type 1 diabetes (EXTOD - see attached leaflet). Blood glucose will be checked immediately following exercise and corrected with fast acting carbohydrates if low. The investigators will also advise the subjects to check their glucose level before bed, and if necessary in the early hours of the morning (through setting an alarm clock) if this is required.

Flash Glucose Monitoring Analysis 9 key metrics of glycaemic control will be assessed, reported in 3 time blocks (sleep 00:00-06:00, wake 06:00- 00:00 and 24h 00:00- 00:00): 1) mean glucose, 2) % of time in level 2 hypoglycaemia (<3.0mmol/L), 3) % of time in level 1 hypoglycaemia (3.0-3.9mmol/L), 4) % of time in target range (3.9-10.0mmol/L), 5) % of time in level 1 hyperglycaemia (10.0-13.9mmol/L), 6) % of time in level 2 hyperglycaemia (>13.9mmol/L), 7) glycaemic variability, reported as CV and SD, 8) episodes of hypoglycaemia and hyperglycaemia and 9) area under the curve of episodes of hypoglycaemia and hyperglycaemia.

研究类型

介入性

注册 (实际的)

24

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Liverpool、英国、L33AF
        • Matthew Cocks

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 55年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • T1D diagnosis more than 6 months ago
  • Using a basal bolus insulin regime or insulin pump therapy
  • BMI ≤ 32 kg.m-2

Exclusion Criteria:

  • Pregnancy (or planning pregnancy)
  • Disability preventing participation in an exercise regime
  • Angina
  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
无干预:控制
参与者将继续他们习惯的生活方式,但 2 周内不进行运动
有源比较器:中等强度持续训练
参与者将在 2 周的干预期内完成中等强度的连续训练
参与者将在 2 周的干预期内完成 6 节中等强度的连续训练。 参与者将被要求完成 30 分钟的连续锻炼。
实验性的:高强度间歇训练
参与者将在 2 周的干预期内完成高强度间歇训练
参与者将在 2 周的干预期内完成 6 节高强度间歇训练。 该计划包括重复 1 分钟的简单原地运动,中间穿插 1 分钟的休息。

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Severe hypoglycaemia (using continuous glucose monitoring)
大体时间:Over a 2 week intervention period
Number of severe hypoglycaemic events (<3mmol/l) during the 2 week intervention period
Over a 2 week intervention period

次要结果测量

结果测量
措施说明
大体时间
Mean glucose (using continuous glucose monitoring)
大体时间:Over a 2 week intervention period
mean glucose level over 2 week recording period
Over a 2 week intervention period
% of time in level 2 hypoglycaemia (<3.0mmol/L) (using continuous glucose monitoring)
大体时间:Over a 2 week intervention period
% of time in level 2 hypoglycaemia (<3.0mmol/L) over 2 week recording period
Over a 2 week intervention period
% of time in level 1 hypoglycaemia (3.0-3.9mmol/L) (using continuous glucose monitoring)
大体时间:Over a 2 week intervention period
% of time in level 1 hypoglycaemia (3.0-3.9mmol/L) over 2 week recording period
Over a 2 week intervention period
% of time in target range (3.9-10.0mmol/L) (using continuous glucose monitoring)
大体时间:Over a 2 week intervention period
% of time in target range (3.9-10.0mmol/L) over 2 week recording period
Over a 2 week intervention period
% of time in level 1 hyperglycaemia (10.0-13.9mmol/L) (using continuous glucose monitoring)
大体时间:Over a 2 week intervention period
% of time in level 1 hyperglycaemia (10.0-13.9mmol/L) over 2 week recording period
Over a 2 week intervention period
% of time in level 2 hyperglycaemia (>13.9mmol/L) (using continuous glucose monitoring)
大体时间:Over a 2 week intervention period
% of time in level 2 hyperglycaemia (>13.9mmol/L) over 2 week recording period
Over a 2 week intervention period
glycaemic variability (using continuous glucose monitoring)
大体时间:2 weeks
Standard deviation in glucose concentrations obtained over a 2 week period using a continuous glucose monitoring device.
2 weeks
area under the curve of episodes of hypoglycaemia and hyperglycaemia
大体时间:Over a 2 week intervention period
area under the curve of episodes of hypoglycaemia and hyperglycaemia 2 week recording period
Over a 2 week intervention period

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年10月1日

初级完成 (实际的)

2019年8月1日

研究完成 (实际的)

2019年8月1日

研究注册日期

首次提交

2018年6月25日

首先提交符合 QC 标准的

2021年9月10日

首次发布 (实际的)

2021年9月14日

研究记录更新

最后更新发布 (实际的)

2021年9月14日

上次提交的符合 QC 标准的更新

2021年9月10日

最后验证

2021年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

No individual participant data will be shared outside the research team. Anonymised group data will be presented in research articles and presentations

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅