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NCT Number: NCT07565935

Effects of HIIT Following PTR Programme

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nottingham, Royal Derby Hospital Centre

Derby, DE22 3DT, United Kingdom

Location contact

Iskandar Idris

CONTACT

[email protected]

+441332724605

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

High-intensity interval training

Primary outcomes

  1. Pancreatic beta cell function

    Time frame: 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

Secondary outcomes

  1. Insulin sensitivity

    Time frame: 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

  2. Overall glycaemic control

    Time frame: Assessed at baseline and then follow-up (16 weeks)

    From measurement of glycated haemoglobin (HbA1c)

  3. Body weight

    Time frame: Assessed at baseline and then follow-up (16 weeks)

    Measurement of participant weight

  4. Body composition

    Time frame: Assessed at baseline and then follow-up (16 weeks)

    Measurement of fat mass and fat-free mass using bioimpedance analysis

  5. Skeletal muscle function

    Time frame: Assessed at baseline and then follow-up (16 weeks)

    Assessed using muscle strength (1 repetition maximum) testing and electromyography

  6. Skeletal muscle structure

    Time frame: Assessed at baseline and then follow-up (16 weeks)

    Using muscle ultrasonography to assess muscle thickness, cross sectional area and fibre pennation angle

  7. Cardiorespiratory fitness

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Oluwaseun Anyiam

CONTACT

[email protected]

+441332724605

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Association of British Clinical Diabetologists

Registry information

Official study title

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

Acronym: HIITpostLCD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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