RecruitingInterventional

Ethnic differences in type 2 diabetes pathophysiology

The DIVERSE Study is looking into how people from different ethnic groups respond to a special low-calorie diet for type 2 diabetes. Most past research has focused on White Europeans, so this study is particularly interested in Black African and Caribbean individuals. Researchers will check changes in blood sugar, body weight, fat in organs like the liver and pancreas, and how well insulin works, both before and after a twelve-week diet plan. The main goal is to figure out why some people get better results than others and to help create more suitable and fair diabetes treatments for everyone. This study hopes to lead to better, more personalised care for people with type 2 diabetes from various backgrounds.

At a glance

Status

Recruiting

Sponsor

University of Leicester

Enrolment target

Start

01 Apr 2026

Estimated completion

01 Aug 2028

Diabetes - Type 2

What is this study about?

The DIVERSE Study is trying to understand why a diet that helps manage type 2 diabetes might work differently for people from various ethnic backgrounds. We know that type 2 diabetes affects many people, and a special low-calorie diet can be very helpful in managing it. However, most of what we know about these diets comes from studies involving mainly White European individuals. This means we don't have enough information about how effective these diets are, or how they work, for people from other backgrounds, especially those of Black African and Caribbean descent.

This study will compare how people of Black African, Caribbean, and White European backgrounds respond to a twelve-week low-calorie diet. Researchers will carefully look at important health markers like blood sugar levels, changes in body weight, and how much fat is stored in organs like the liver and pancreas, which are very important for managing diabetes. They will also check how well the body's insulin works, as insulin is key for controlling blood sugar.

The main aim is to discover what causes these differences in response. By understanding why some people do better on the diet than others, regardless of their ethnic background, the study hopes to pave the way for more fair and personalised treatments for type 2 diabetes. Ultimately, this research aims to improve diabetes care for everyone, making sure treatments are effective and tailored to individual needs.

Key takeaways

Focuses on how diet affects type 2 diabetes in different ethnic groups.
Compares Black African, Caribbean, and White European participants.
Involves a 12-week low-calorie diet and various health checks.
Aims to improve fair and personalised diabetes treatments.
Participation lasts about 14 weeks with 11 visits.
Risks are minimal; you can withdraw anytime.

Who may be eligible?

This study is looking for volunteers between 40 and 65 years old who have type 2 diabetes. Your weight should be within a certain range (BMI between 27 and 45). You must have been diagnosed with type 2 diabetes within the last six years, and your latest HbA1c (a measure of blood sugar over time) should be above a certain level. If your HbA1c is a bit lower, you should still be taking medication for your diabetes.

To join, you need to be willing to give your informed consent, which means you understand and agree to take part. You also need to be able to understand and speak English.

There are some reasons why you might not be able to join. For example, if you are currently using insulin, have a very high HbA1c, have recently lost a lot of weight unintentionally, have severe kidney or heart problems, or are pregnant. Also, if you are currently in another clinical trial, have had a recent heart attack, or are taking certain medications, you might not be eligible. This is to make sure the study is safe for you and that the results are clear.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 40 and 65 years old?
Do you have type 2 diabetes?
Were you diagnosed with type 2 diabetes in the last 6 years?
Are you able to attend appointments in Leicester, UK?
Do you speak and understand English?
Are you *not* currently using insulin?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved for about 14 weeks. You'll need to attend 11 visits in total, mostly at the Leicester Diabetes Centre. One of these visits, for a special scan, will be at Glenfield Hospital. Your participation starts with some initial health checks and continues through the twelve-week diet period and a final assessment.

During the study, you'll have regular health checks, blood tests, and your blood sugar and activity levels will be monitored. You'll wear a continuous glucose monitor (CGM) and an activity tracker for a period. You'll also be asked to keep a food diary to record what you eat. There will be special scans (DEXA and MRI) to look at your body composition and fat in your organs. To get a deeper understanding, small samples of your muscle and fat tissue will be taken (biopsies) to study how insulin works and how your body uses energy.

The main part of the study involves following a twelve-week very low-calorie diet using special meal replacement products. Throughout this time, you'll have regular meetings with dietitians who will support you and monitor your progress.

Potential risks and benefits

Taking part in this study might help you learn more about how your body responds to weight loss and changes in blood sugar, though there's no guarantee of personal health benefits. Your participation will definitely help researchers better understand diabetes and contribute to better care for people from all backgrounds. The risks are very small. You might feel a little discomfort from blood tests or slight soreness/bruising from the small tissue samples (biopsies). The special scans (DEXA) use a tiny amount of radiation, similar to everyday exposure, which is considered very safe. All procedures are carried out by trained medical staff to ensure your safety and comfort. Remember, your participation is completely voluntary, and you can choose to leave the study at any time, for any reason.

Locations (1)

Leicester Diabetes Centre
Approximate
Leicester, England

Common questions

What is the main goal of the DIVERSE Study?

To understand how different ethnic groups respond to a low-calorie diet for type 2 diabetes, especially Black African/Caribbean and White European individuals.

How long will I be involved in the study?

Your involvement, from initial checks to final assessments, will last approximately 14 weeks.

Where will the study visits take place?

Most visits will be at the Leicester Diabetes Centre, with one MRI scan at Glenfield Hospital in Leicester.

What kind of diet will I follow?

You'll follow a twelve-week very low-calorie diet using special meal replacement products, with support from dietitians.

Who is funding this research?

The study is funded by Diabetes UK, with extra help from the Leicester Biomedical Research Centre, and sponsored by the University of Leicester.

How to find out more

Gráinne Whelehan

g.whelehan@leicester.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.