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Effects of HIIT Following PTR Programme (HIITpostLCD)

2026年4月29日 更新者：University of Nottingham

Can High-Intensity Interval Training (HIIT) Reduce the Risk of Diabetes Relapse Following Discharge From the NHS Path to Remission Programme? - a Pilot Study

Caloric restriction programmes are highly effective and safe interventions for inducing rapid weight loss and improvements in glycaemic control. The landmark DiRECT study showed that 68% of people completing a caloric restriction intervention achieved remission of type 2 diabetes (T2D) by one year. Consequently, the NHS Path to Remission (PTR) programme was developed to stimulate diabetes remission in individuals that meet certain criteria. Unfortunately, long-term follow-up of the DiRECT study suggests that in the majority of participants that achieved remission, diabetes relapses within 5 years. This necessitates a focus on identifying methods to improve long-term maintenance of diabetes remission.

High-intensity interval training (HIIT) involves several brief bursts of intense exercise, interspersed with recovery breaks, and is becoming increasingly popular. HIIT can cause improvements in cardiovascular fitness, reduce blood pressure, and lower body fat content in only a fraction of the time of traditional exercise methods. Specific to T2D, HIIT has been shown to improve pancreatic beta cell function, which is critically important for maintenance of long-term diabetes remission.

This pilot study is being conducted to determine whether participating in a home-based HIIT training programme may help maintain beta cell function in individuals that have achieved diabetes remission following the NHS PTR programme. The study will take place at the Royal Derby Hospital.

The intention is to recruit 20 participants from Derbyshire or Nottinghamshire that have achieved diabetes remission in the NHS PTR programme. Participants will be recruited following discharge from the programme and allocated to either perform a HIIT training programme (intervention group), or continue with usual care (control group) for 16 weeks.

Before starting, participants will attend the research department to have initial measurements taken including bioimpedance, fasting bloods, an intravenous glucose tolerance test, muscle ultrasound, electromyography and cardiopulmonary exercise testing. Following this, those in the intervention group will be asked to perform a home-based HIIT training programme 3 times per week and record details of each session in a booklet. The control group will be asked to continue with their habitual levels of physical activity. Participants will be contacted regularly to ensure their safety and compliance.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

20

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。

学习联系方式

学习地点

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adults between the age of 18-70 years
  • Ability to provide informed consent
  • Completed the NHS Path to Remission programme and achieved diabetes remission (HbA1c <48mmol/mol (6.5%), and off diabetes medications for at least three months)

Exclusion Criteria:

  • BMI > 40kg/m2
  • Current participation in a formal exercise regime
  • Current pregnancy or breastfeeding
  • Uncontrolled hypertension (blood pressure >160/100mmHg)

  • History of cardiovascular disease:

    • Symptomatic angina
    • Heart failure (class III/IV)
    • Significant arrhythmias
    • Right to left cardiac shunt
    • Recent acute coronary syndrome
    • Severe aortic valvular disease
    • Active cardiac infection

  • Background of the following respiratory diseases:

    • Pulmonary hypertension
    • Significant COPD
    • Uncontrolled asthma
  • History of malignancy undergoing current treatment or palliation
  • Presence of significant musculoskeletal, neurological or cerebrovascular disease
  • Any other medical condition deemed by the investigators to preclude inclusion into the study

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：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：HIIT group
This group will perform 16 weeks of high-intensity interval training. This will involve performing a 15-minute routine, three times a week. The exercise programme includes star jumps, standing squats, on-the-spot sprints, then repeating standing squats and star jumps again (this pyramid design has been chosen as it can be used to provide participants with a target of repetitions to achieve in the 4th and 5th interval).
行为的：Exercise
High-intensity interval training
无干预：Control group
This is the control group and will be asked to perform their usual habitual levels of activity for the 16 weeks of the study.

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
Pancreatic beta cell function
大体时间：Assessed at baseline and then follow-up (16 weeks)
Assessment of beta-cell function using insulin first phase response from an intravenous glucose tolerance test
Assessed at baseline and then follow-up (16 weeks)

次要结果测量

结果测量
措施说明
大体时间
Insulin sensitivity
大体时间：Assessed at baseline and then follow-up (16 weeks)
Measured during the intravenous glucose tolerance test (IVGTT) and calculated from fasting glucose and insulin using the homeostatic model of assessment for insulin resistance
Assessed at baseline and then follow-up (16 weeks)
Overall glycaemic control
大体时间：Assessed at baseline and then follow-up (16 weeks)
From measurement of glycated haemoglobin (HbA1c)
Assessed at baseline and then follow-up (16 weeks)
Body weight
大体时间：Assessed at baseline and then follow-up (16 weeks)
Measurement of participant weight
Assessed at baseline and then follow-up (16 weeks)
Body composition
大体时间：Assessed at baseline and then follow-up (16 weeks)
Measurement of fat mass and fat-free mass using bioimpedance analysis
Assessed at baseline and then follow-up (16 weeks)
Skeletal muscle function
大体时间：Assessed at baseline and then follow-up (16 weeks)
Assessed using muscle strength (1 repetition maximum) testing and electromyography
Assessed at baseline and then follow-up (16 weeks)
Skeletal muscle structure
大体时间：Assessed at baseline and then follow-up (16 weeks)
Using muscle ultrasonography to assess muscle thickness, cross sectional area and fibre pennation angle
Assessed at baseline and then follow-up (16 weeks)
Cardiorespiratory fitness
大体时间：Assessed at baseline and then follow-up (16 weeks)
Determined from be the highest rate of oxygen consumption obtained (VO2max) during a cardiopulmonary exercise test
Assessed at baseline and then follow-up (16 weeks)

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。

赞助

University of Nottingham

合作者

Association of British Clinical Diabetologists

调查人员

  • 首席研究员：Iskandar Idris、University of Nottingham

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 (估计的)

2026年5月1日

初级完成 (估计的)

2027年1月1日

研究完成 (估计的)

2027年5月1日

研究注册日期

首次提交

2026年3月24日

首先提交符合 QC 标准的

2026年4月29日

首次发布 (实际的)

2026年5月4日

研究记录更新

最后更新发布 (实际的)

2026年5月4日

上次提交的符合 QC 标准的更新

2026年4月29日

最后验证

2026年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 24057

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

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

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