RecruitingNAINTERVENTIONAL

Diabetes Interventional Assessment of Slimming or Training to Lessen Inconspicuous Cardiovascular Dysfunction

This study, called "Diabetes Interventional Assessment of Slimming or Training to Lessen Inconspicuous Cardiovascular Dysfunction" (DIAMOND), explores how type 2 diabetes impacts the heart in younger adults. Many people with type 2 diabetes are at higher risk of heart problems. Even at a young age, subtle heart abnormalities can be present. We want to see if losing weight through a special low-calorie diet or regular exercise can improve the heart's pumping ability and reduce fat in the liver and heart. We will compare these approaches to standard diabetes care to understand which methods are most effective and why, ultimately aiming to improve heart health for those with type 2 diabetes.

At a glance

Status

Recruiting

Phase

Sponsor

University of Leicester

Enrolment target

120

Start

02 Oct 2015

Estimated completion

31 Aug 2028

Diabetes

What is this study about?

Many younger adults are now being diagnosed with type 2 diabetes. This can be a concern because having diabetes for a long time significantly increases the risk of developing heart problems later in life. Even when young, some people with type 2 diabetes might have small changes in their heart that aren't obvious but could lead to more serious conditions like heart failure.

This study aims to understand these changes better. We'll use detailed scans and other tests to see how type 2 diabetes affects the heart's structure and how well it pumps blood. We're also very interested in whether we can improve these heart issues. We believe that losing weight could play a key role, as there's growing evidence that type 2 diabetes can even be reversed with weight loss.

So, we will be comparing two approaches: a special low-calorie diet plan and a structured exercise programme. We want to see if either of these can fix the fatty changes often seen in the liver and heart of people with type 2 diabetes, which we hope will lead to a healthier, better-functioning heart. We'll compare results from these groups with a group receiving standard diabetes care, and also try to figure out exactly how any improvements happen, perhaps by looking at changes in body fat and other health markers.

Key takeaways

This study investigates how type 2 diabetes affects the heart in younger adults.
It compares a special diet, exercise, and standard care for improving heart health.
Participation involves detailed heart scans and health checks.
The study aims to potentially reverse fatty changes in the liver and heart.
It's for people aged 18-65 with type 2 diabetes, meeting specific health criteria.

Who may be eligible?

To join this study, you need to be an adult between 18 and 65 years old who has been diagnosed with type 2 diabetes for at least three months, but not longer than 12 years. Your diabetes management needs to fit certain criteria – for example, if you're on triple therapy, your blood sugar levels (measured by HbA1c) should be 9% or less, or up to 10% if you're on diet and exercise alone or have simpler medication regimens. You also need to have a body mass index (BMI) over 30 (or over 27.5 if you are of South Asian descent) and have been diagnosed with type 2 diabetes before the age of 60.

There are also some reasons why you wouldn't be able to join. For example, if you've recently lost a lot of weight (more than 5kg in the last six months), or if you have severe kidney disease, known heart problems like heart failure or certain heart rhythm issues, or if you're taking specific medications like insulin or steroids. You also can't join if you have certain inflammatory conditions or can't exercise or undergo an MRI scan.

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 18 and 65 years old?
Have you had type 2 diabetes for at least 3 months but not more than 12 years?
Is your BMI (Body Mass Index) over 30 (or over 27.5 if you are of South Asian origin)?
Have you NOT had major weight loss (more than 5kg) in the last 6 months?
Do you currently NOT take insulin, steroids, or have known heart failure or severe kidney disease?

Answer every question to see your result.

What does participation involve?

If you take part, you'll first have some detailed heart scans and other tests to get a baseline picture of your health. After these initial assessments, you'll be randomly assigned to one of three groups: a group following a special low-calorie diet plan (Cambridge Weight Plan), a group doing supervised exercise sessions, or a group receiving standard diabetes care. The main part of the study will last for 12 weeks during which you'll follow your assigned plan. Towards the end of this 12-week period, you'll have more scans and tests to see how things have changed. We'll also ask you to come back for follow-up appointments between 6 and 12 months after the main study period to check on your long-term health. The total time you're involved could be over a year, including follow-up.

Potential risks and benefits

Taking part in this study could offer several potential benefits, such as receiving specialised support for weight loss or exercise, which might improve your diabetes control and heart health. You'll also get detailed health assessments that might give you a better understanding of your own health. However, there are potential risks, like any side effects from the diet plan (such as temporary tiredness or headaches) or from starting a new exercise routine. Some of the scans involve magnets (MRI) and could be noisy or make you feel a bit claustrophobic. It's important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Glenfield Hospital (University Hospitals of Leicester NHS Trust)
Verified postcode
Leicester, United Kingdom· Recruiting

Common questions

What is type 2 diabetes?

Type 2 diabetes is a common condition where your body doesn't produce enough insulin, or the insulin it does produce doesn't work properly. This means your blood sugar levels can get too high.

What is an HbA1c test?

HbA1c is a blood test that shows your average blood sugar level over the past 2 to 3 months. It's a key indicator of how well your diabetes is being managed.

What is a 'low-calorie diet' in this study?

The low-calorie diet in this study is the Cambridge Weight Plan, which is a structured programme designed to help with weight loss.

Will I have to pay to join this study?

No, you will not have to pay to participate in this study. All study-related treatments and assessments are provided for free.

What does 'randomly assigned' mean?

It means you'll be put into one of the study groups by chance, like flipping a coin. This ensures the study is fair and accurate.

How to find out more

Gerry P McCann, MD

gerry.mccann@uhl-tr.nhs.uk 0116 258 Official trial record

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