Can High-Intensity Interval Training (HIIT) Reduce the Risk of Diabetes Relapse Following Discharge From the NHS Path to Remission Programme? - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pancreatic beta cell function
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Exercise (Behavioral)
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.
结局指标
主要结局
Pancreatic beta cell function
时间窗: 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
次要结局
- Insulin sensitivity(Assessed at baseline and then follow-up (16 weeks))
- Overall glycaemic control(Assessed at baseline and then follow-up (16 weeks))
- Body weight(Assessed at baseline and then follow-up (16 weeks))
- Body composition(Assessed at baseline and then follow-up (16 weeks))
- Skeletal muscle function(Assessed at baseline and then follow-up (16 weeks))
- Skeletal muscle structure(Assessed at baseline and then follow-up (16 weeks))
- Cardiorespiratory fitness(Assessed at baseline and then follow-up (16 weeks))