RecruitingOBSERVATIONAL

Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus

This study aims to understand why people with type 2 diabetes often develop heart problems. We're looking at early signs of heart issues that might not yet cause symptoms. By using special scans and tests, we hope to find out what specifically causes these changes in the heart. We'll compare people with type 2 diabetes to healthy volunteers. The results could help doctors find new treatments and ways to prevent serious heart disease in people living with diabetes.

At a glance

Status

Recruiting

Sponsor

University of Leicester

Enrolment target

593

Start

24 Oct 2017

Estimated completion

31 Oct 2029

Diabetes Mellitus, Type 2 Diabetic Cardiomyopathies

What is this study about?

You might know that having type 2 diabetes can increase your risk of heart problems. This study is trying to understand *why* and *how* these heart issues begin, often before people even notice any symptoms. We call these early changes 'subclinical,' meaning they are there but not yet causing obvious problems.

The main goal is to figure out what causes these early heart changes in people with type 2 diabetes. We'll be using several types of advanced scans and tests to get a very detailed picture of the heart. By comparing people with type 2 diabetes to a group of healthy volunteers, we hope to identify specific factors that lead to heart problems. This research is important because if we can understand these early causes, we might be able to develop new treatments or ways to stop heart disease from getting worse in people with diabetes.

The information we gather could help doctors get better at spotting heart problems earlier and finding new ways to keep hearts healthy for people with type 2 diabetes. This study does not involve new medications, but rather uses existing scanning and testing methods to learn more about the heart.

Key takeaways

This study helps us understand early heart changes in type 2 diabetes.
It uses special scans and tests, not new medicines.
Participation provides detailed information about your own heart.
The findings could lead to new ways to prevent and treat heart disease.
You can stop participating at any time.
Common conditions like obesity won't stop you from joining.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old and have a clear diagnosis of type 2 diabetes from your doctor. We are interested in people who generally feel stable with their diabetes.

However, there are certain reasons why you wouldn't be able to join. For example, if you have severe chest pain or breathlessness, have had a heart attack or stroke, or have certain serious heart conditions like an irregular heartbeat (atrial fibrillation) or significant problems with your heart valves, then this study wouldn't be right for you.

We also can't include people with certain kidney problems, or those with type 1 diabetes. Don't worry if you have common conditions like obesity or high blood pressure, as these won't stop you from taking part.

Quick self-check

Are you between 18 and 75 years old?
Do you have a clear diagnosis of type 2 diabetes from your GP?
Have you NOT had a heart attack, stroke, or major heart surgery?
Do you NOT have severe chest pain or breathlessness?
Do you NOT have serious kidney disease?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll have several visits to the study centre. These visits will involve various tests, including special heart scans (like MRI scans, which use strong magnets, and echocardiograms, which use sound waves), a CT scan to check your heart's arteries, and an exercise test to see how well your heart works when you're active. You'll also have blood tests and wear a blood pressure monitor for a day, along with a special watch to track your activity. You won't be given any new medications as part of the study. The total duration of your participation will involve these appointments, which will be spread out over time.

Potential risks and benefits

By taking part, you’ll be helping us learn more about heart health in people with type 2 diabetes, which could benefit many others in the future. You'll also receive detailed information about your own heart health from the tests. As with any medical procedure, there are some minor risks associated with the tests, such as discomfort during blood draws or claustrophobia during MRI scans. You will be fully informed about these before any tests are done. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University of Leicester
Leicester, United Kingdom· Recruiting

Common questions

Will I have to take new medicine in this study?

No, this study does not involve giving you any new medications. We are using scans and tests to learn more about the heart.

What kind of scans will be done?

You might have heart MRI scans, an echocardiogram (a heart ultrasound), and a CT scan of your heart to look at your arteries.

Will I find out my own test results?

Yes, you will receive information about your own heart health as a result of the detailed tests you undergo.

How long will the study take?

The study involves a series of appointments for tests, but the exact total duration will be explained to you when you consider joining.

Can I stop being in the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, and it won't affect your regular medical care.

How to find out more

Gerry P McCann, MD

gpm12@le.ac.uk 01162583402 Official trial record

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