Effects of HIIT Following PTR Programme

NCT07565935 | Not Yet Recruiting

• 1 other identifier: 24057
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity & Overweight; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Pancreatic beta cell function

  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)

Secondary Outcomes (7)

• 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)

Study Arms (2)

HIIT group

EXPERIMENTAL

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).

Behavioral: Exercise

Control group

NO INTERVENTION

This is the control group and will be asked to perform their usual habitual levels of activity for the 16 weeks of the study.

Interventions

Exercise BEHAVIORAL

High-intensity interval training

HIIT group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead
• Association of British Clinical Diabetologists: collaborator

Study Sites (1)

University of Nottingham, Royal Derby Hospital Centre

Derby, DE22 3DT, United Kingdom

Location

MeSH Terms

Conditions

Obesity; Overweight; Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Iskandar Idris

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oluwaseun Anyiam

CONTACT

+441332724605; oluwaseun.anyiam1@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-03

Locations

GB (1)