Obesity & OverweightHIITpostLCDNCT07565935
Effects of HIIT Following PTR Programme
A study testing Exercise in people with Obesity & Overweight and Type 2 Diabetes, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity & Overweight, Type 2 Diabetes
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
University of Nottingham, Royal Derby Hospital Centre
Derby, DE22 3DT
Iskandar Idris, +441332724605, iskandar.idris@nottingham.ac.uk
About this study
Official 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
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.
Read more
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
- Being tested
- Exercise
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
High-intensity interval training
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic beta cell function
Assessment of beta-cell function using insulin first phase response from an intravenous glucose tolerance test
Measured: Assessed at baseline and then follow-up (16 weeks)
Secondary outcomes (7)
Insulin sensitivity
Measured during the intravenous glucose tolerance test (IVGTT) and calculated from fasting glucose and insulin using the homeostatic model of assessment for insulin resistance
Measured: Assessed at baseline and then follow-up (16 weeks)
Overall glycaemic control
From measurement of glycated haemoglobin (HbA1c)
Measured: Assessed at baseline and then follow-up (16 weeks)
Body weight
Measurement of participant weight
Measured: Assessed at baseline and then follow-up (16 weeks)
Body composition
Measurement of fat mass and fat-free mass using bioimpedance analysis
Measured: Assessed at baseline and then follow-up (16 weeks)
Skeletal muscle function
Assessed using muscle strength (1 repetition maximum) testing and electromyography
Measured: Assessed at baseline and then follow-up (16 weeks)
Skeletal muscle structure
Using muscle ultrasonography to assess muscle thickness, cross sectional area and fibre pennation angle
Measured: Assessed at baseline and then follow-up (16 weeks)
Cardiorespiratory fitness
Determined from be the highest rate of oxygen consumption obtained (VO2max) during a cardiopulmonary exercise test
Measured: Assessed at baseline and then follow-up (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study startMay 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Association of British Clinical Diabetologists
- Responsible party
- Sponsor
- Investigators
- Iskandar Idris, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565935
- Sponsor's protocol ID
- 24057
- Acronym
- HIITpostLCD
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07565935
- Acronym / sponsor ID
- HIITpostLCD / 24057
- Conditions
- Obesity & Overweight, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Association of British Clinical Diabetologists
- Study start
- May 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIIT group | Experimental | Behavioral: ExerciseThis 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). |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (19 listed)
- BMI > 40kg/m2
- Current participation in a formal exercise regime
- Current pregnancy or breastfeeding
- Uncontrolled hypertension (blood pressure >160/100mmHg)
- History of cardiovascular disease:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseHigh-intensity interval training | Behavioural | HIIT group |
Primary outcome
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
7 secondary outcomes
Insulin sensitivity
Time frame: Assessed at baseline and then follow-up (16 weeks)
Overall glycaemic control
Time frame: Assessed at baseline and then follow-up (16 weeks)
Body weight
Time frame: Assessed at baseline and then follow-up (16 weeks)
Body composition
Time frame: Assessed at baseline and then follow-up (16 weeks)
Skeletal muscle function
Time frame: Assessed at baseline and then follow-up (16 weeks)
Skeletal muscle structure
Time frame: Assessed at baseline and then follow-up (16 weeks)
Cardiorespiratory fitness
Time frame: Assessed at baseline and then follow-up (16 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Iskandar Idris principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Obesity & Overweight and Type 2 Diabetes, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oluwaseun Anyiam (+441332724605, oluwaseun.anyiam1@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreatic beta cell function (time frame: Assessed at baseline and then follow-up (16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.