RecruitingOBSERVATIONAL

Prognostic Imaging Biomarkers for Diabetic Kidney Disease

This study aims to discover new ways to identify worsening kidney disease in people with diabetes using special scans like MRI and ultrasound. Diabetic kidney disease is a common and serious complication of diabetes, often leading to dialysis or kidney transplants. While medication helps, there's currently no cure once it starts. Researchers believe that new measurements from these scans could detect early signs of kidney damage, even before blood or urine tests show a problem. This could help doctors understand who needs treatment most urgently. The study will follow 500 patients in Europe for four years to see if these scan measurements can predict who is at risk of their kidney disease getting worse.

At a glance

Status

Recruiting

Sponsor

University of Leeds

Enrolment target

500

Start

01 Sep 2018

Estimated completion

01 Sep 2038

Diabetic Kidney Disease

What is this study about?

If you have diabetes, you might know that it can sometimes affect your kidneys. This is called diabetic kidney disease, and it's a really common and serious problem. Sadly, it's often the main reason people need dialysis or a kidney transplant. While medicines can help slow it down, once this kidney damage starts, it can't currently be cured, and many people find their health gets worse.

Doctors are always looking for better ways to protect your kidneys. This study is exciting because it's trying to find new clues from special scans, like MRI (Magnetic Resonance Imaging) and ultrasound, to see who might be at higher risk of their kidney disease getting worse. Think of these scans as giving doctors a peek inside your kidneys to spot very early changes, such as issues with blood flow or scarring, which current tests might not pick up.

The researchers hope that these new scan measurements will help doctors identify people who might need a different approach to their care sooner. They'll be watching 500 patients with early-stage diabetic kidney disease for four years, carefully looking at their scan results and other health information. The goal is to see if these early scan changes can predict who will have their kidney disease worsen over time.

Key takeaways

This study is looking for new ways to spot kidney problems early in people with diabetes.
It uses special scans like MRI and ultrasound to find hidden signs of kidney damage.
The goal is to help doctors predict who needs treatment most urgently to prevent their kidney disease from getting worse.
500 patients will be followed for four years to see if these scan measurements can predict future kidney decline.
Taking part involves a full health check at the start, including scans, and then yearly follow-up visits for blood and urine tests.

Who may be eligible?

To join this study, you would need to have Type 2 Diabetes and your kidney function, measured by eGFR, should be at least 30 ml/min. You also need to be between 18 and 80 years old and able to understand and agree to take part. Importantly, your diabetes and blood pressure medicines should have been stable for the last three months, meaning no changes to the type or amount of medicine you take.

There are some reasons why you wouldn't be able to join. For example, if you've had an organ transplant (except for an eye transplant), are on permanent dialysis, or have a serious health condition that might mean you wouldn't live for at least another year. You also can't join if you are pregnant, have certain types of hepatitis, or specific types of cancer. If you have any metal implants that are not safe for an MRI scan, such as a pacemaker or certain aneurysm clips, or if you are very claustrophobic, you wouldn't be able to participate. The study also cannot include you if you weigh more than 250 kg.

Quick self-check

I have Type 2 Diabetes.
My kidney function is not severely reduced (eGFR is 30 or higher).
I am between 18 and 80 years old.
My diabetes and blood pressure medicines haven't changed in the last 3 months.
I do not have a pacemaker or other metal implant that would prevent an MRI scan.

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

What does participation involve?

If you join this study, it will last for a total of four years. At the very beginning, you'll have a detailed health check-up, which includes sharing your health history, having blood and urine samples taken, and undergoing MRI and ultrasound scans of your kidneys. You'll then have follow-up visits once a year for the next three years (so four visits in total across the four years).

During these yearly follow-up visits, the research team will collect similar information, including blood and urine samples and an updated health check. You will only have the MRI and ultrasound scans at the very start of the study. It's important that your diabetes and blood pressure medications remain stable, and you shouldn't be starting any new or experimental drugs outside of your usual care. All the information and samples collected will be made anonymous to protect your privacy.

Potential risks and benefits

Taking part in a study like this might not directly benefit your health immediately, but it helps doctors learn more about diabetic kidney disease, which could lead to better care for others in the future. As for risks, you'll have blood draws, which carry a small risk of bruising or discomfort. The MRI scan involves lying in a large machine, which some people find noisy or claustrophobic, and there's a small chance of reaction to the contrast dye used. Ultrasound scans are generally very safe. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Turun Yliopisto
Turku, Finland· Recruiting
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France· Not yet recruiting
Università degli Studi di Bari Aldo Moro
Bari, Italy· Not yet recruiting
Lund University Diabetes Centre
Malmö, Sweden· Active not recruiting
Swiss Institute of Bioinformatics
Lausanne, Switzerland· Active not recruiting
University of Exeter
Exeter, United Kingdom· Not yet recruiting
University of Leeds
Leeds, United Kingdom· Recruiting

Common questions

What is 'diabetic kidney disease'?

It's a serious problem where diabetes starts to damage your kidneys, making them not work as well as they should.

Why are you using MRI and ultrasound?

Researchers hope these scans can show very early signs of kidney damage that current blood and urine tests might miss, helping doctors act sooner.

Will I get my scan results?

The study aims to gather general information to improve understanding of diabetic kidney disease, not to provide individual results for your direct medical care.

How long does the study last if I join?

If you take part, you'll be involved for a total of four years, with an initial visit and then yearly check-ups.

Do I have to stop my current medications?

No, you should continue your current medications, but it's important that your diabetes and blood pressure medicines have been stable for the past three months.

How to find out more

Steven Sourbron, PhD

s.sourbron@leeds.ac.uk 0044-113-34-38003 Official trial record

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