Ethnic differences in type 2 diabetes pathophysiology
| ISRCTN | ISRCTN18241480 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18241480 |
| Integrated Research Application System (IRAS) | 351268 |
| Central Portfolio Management System (CPMS) | 65477 |
| Sponsor | University of Leicester |
| Funder | Diabetes UK |
- Submission date
- 20/02/2026
- Registration date
- 27/02/2026
- Last edited
- 10/03/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
The DIVERSE Study investigates how people from different ethnic backgrounds respond to a very low calorie diet designed to manage type 2 diabetes (T2D). Previous research has largely focused on White European participants, with limited data on Black African and Caribbean populations. This study compares changes in blood sugar, body weight, fat in organs such as the liver and pancreas, and insulin function before and after a twelve-week diet. The aim is to understand why some people respond better than others and to support the development of more personalised and equitable diabetes treatments.
Who can participate?
The study recruits adults aged 40–65 years with type 2 diabetes who identify as either Black African or Caribbean, or White European. Participation is voluntary, and individuals may withdraw at any point.
What does the study involve?
Participants take part over approximately fourteen weeks and attend 11 visits, mostly at the Leicester Diabetes Centre, with one MRI scan at Glenfield Hospital. The study includes:
• Health checks, blood tests, and monitoring of blood sugar and activity
• Wearing a continuous glucose monitor and physical activity tracker
• Completing a food diary
• Scans to measure body composition and fat in organs (DEXA and MRI)
• Muscle and fat tissue biopsies to study insulin and metabolism
• A twelve-week very low calorie diet using meal replacement products
• Regular consultations with dietitians to monitor progress and provide support
What are the possible benefits and risks of participating?
The study may help participants better understand their personal response to weight loss and blood sugar changes, although benefits are not guaranteed. The research will also contribute to improving diabetes care for diverse populations. Risks are minimal and include mild discomfort from blood sampling, temporary soreness or bruising from biopsies, and negligible exposure to radiation from DEXA scans. All procedures are conducted by trained medical staff.
Where is the study run from?
Leicester Diabetes Centre, with MRI scans at Glenfield Hospital, Leicester, UK.
When is the study starting and how long is it expected to run for?
Individual participation lasts approximately fourteen weeks, from screening to the final assessment.
Who is funding the study?
Funded by Diabetes UK, with additional support from the Leicester Biomedical Research Centre. The study is sponsored by the University of Leicester.
Who is the main contact?
Study team email: uhl-tr.diversestudy@nhs.net
Contact information
Public, Principal investigator, Scientific
University of Leicester
Leicester Diabetes Centre
Leicester
LE5 4PW
United Kingdom
 ORCID ID |
0000-0003-1391-4349 |
|---|---|
| g.whelehan@leicester.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional non randomised |
| Secondary study design | Non randomised study |
| Scientific title | Exploring ethnic differences in the pathophysiological response to a low-energy diet in people with type 2 diabetes |
| Study objectives | The main aim of this study is to find out whether people from different ethnic backgrounds respond differently to a structured weight-loss diet when they have type 2 diabetes. Specifically, we want to understand whether a 12-week low-energy diet improves blood sugar control to the same extent in Black African and Caribbean adults as it does in White European adults with type 2 diabetes. |
| Ethics approval(s) |
Not yet submitted |
| Health condition(s) or problem(s) studied | Diabetes - Type 2 |
| Intervention | Baseline assessments (before the diet starts) Participants attend two detailed assessment visits. These include measurements of weight, body composition, blood sugar levels, scans to measure body and organ fat, and tests to assess how the body handles sugar and insulin. Small samples of muscle and fat tissue are taken under local anaesthetic. Participants also wear glucose and activity monitors and complete food diaries. 12-week low-energy diet Participants follow a low-energy meal-replacement diet for 12 weeks. They attend regular visits (about every 2 weeks) for monitoring, blood tests, body measurements, and dietary support. Participants are closely monitored for safety and side effects. End-of-study assessments After the diet, participants repeat the same tests and scans carried out at the start of the study. This allows researchers to compare changes before and after weight loss. After the study Participants receive support to safely return to normal eating. Some participants may also choose to allow their health data to be followed up through medical records in the future. All procedures are carried out by trained healthcare and research staff, and participants can withdraw at any time. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 01/01/2029 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 40 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 54 |
| Key inclusion criteria | 1. Age 40–65y 2. BMI 27–45kg/m² 3. Diagnosed with T2D within the last 6 years 4. HbA1c value >43mmol/mol,if <48mmol/mol individuals should still be receiving antidiabetic medication (mono or dual therapy) 5. Willing and able to consent to participate in the trial 6. Able to understand written and spoken English |
| Key exclusion criteria | 1. Current use of insulin 2. HbA1c ≥87 mmol/mol 3. Weight loss of >3kg within the past 6 months 4. eGFR of <30 mL/min/m² 5. Heart failure 6. Participation in another clinical interventional trial 7. Substance abuse 8. Known cancer 9. Myocardial infarction within previous 6 months 10. Current treatment with anti-obesity drugs 11. Pregnancy (or consideration of) 12. Use of antipsychotic drugs |
| Date of first enrolment | 01/04/2026 |
| Date of final enrolment | 01/08/2028 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
Gwendolen Road
Leicester
LE5 4PW
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | Not provided at time of registration |
Editorial Notes
10/03/2026: Internal review.
20/02/2026: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
