RecruitingOBSERVATIONAL

Development of a Biomarker Panel for the Earlier Prediction of Acute Kidney Injury in Patients With Diabetes

People with diabetes have a higher risk of developing kidney problems, especially after certain heart procedures that use a special dye. This study aims to find new ways to identify these kidney issues earlier. We believe that by spotting these risks sooner, we can make these essential heart tests and treatments safer for people with diabetes. Currently, we use a test called creatinine, but it doesn't always show kidney problems quickly enough. We're looking for better markers in blood and urine samples from patients with diabetes who are already having a heart procedure. The goal is to improve how we detect and treat these kidney complications, ultimately helping more patients with diabetes get the care they need safely.

At a glance

Status

Recruiting

Sponsor

Barts & The London NHS Trust

Enrolment target

250

Start

24 Jun 2009

Estimated completion

31 Dec 2025

Diabetes Mellitus Renal Impairment

What is this study about?

This study is about understanding and preventing kidney problems in people with diabetes. When someone with diabetes needs an X-ray or procedure for their heart – especially those that use a special dye – there's a higher chance they might develop a type of kidney injury. This is really important because heart disease is very common in people with diabetes, and these procedures are often vital for their health. We want to make sure these necessary tests can be done as safely as possible for everyone.

Currently, doctors look at a substance called creatinine in the blood to check on kidney health. While helpful, it sometimes doesn't show kidney problems right away after a procedure. So, we're searching for new and earlier warning signs, which we call 'biomarkers,' in blood and urine. These biomarkers could help doctors see who is at greater risk of kidney complications much sooner.

By finding these new markers, we hope to improve how doctors identify and manage kidney injury in people with diabetes. This could lead to better treatments and ensure that more patients can safely benefit from crucial heart diagnostic tests and procedures, ultimately improving their long-term health.

Key takeaways

Aims to find earlier warning signs of kidney issues in people with diabetes.
Focuses on patients having heart procedures that use a special dye.
Looks for new 'biomarkers' in blood and urine samples.
Could make heart procedures safer for those with diabetes in the future.
Does not involve new treatments or medications, only extra samples and data collection.
Participation will not affect your routine medical care.

Who may be eligible?

This study is looking for volunteers who are adults (18 years or older) and already have diabetes, or blood sugar levels suggesting they do. You would also need to have some signs of reduced kidney function, which your doctor can explain, and be scheduled to have a specific heart procedure called a PCI (Percutaneous Coronary Intervention).

To join, you must be able to understand what the study involves and be willing to give your written consent. You would also need to agree to provide extra blood and urine samples, and allow the study team to look at your medical records to gather information.

There are certain reasons why someone might not be able to join. For example, if you are pregnant, receiving kidney dialysis, have certain serious infections like HIV or Hepatitis, or if your doctor thinks you are too unwell to participate safely. Also, if you currently have a severe heart condition like cardiogenic shock, you wouldn't be able to join this particular study.

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 18 years old or older?
Do you have diabetes (or are thought to)?
Are you scheduled for a heart procedure called a PCI?
Are you able to agree to give extra blood and urine samples?
Do you have some signs of reduced kidney function (your doctor can confirm this)?
Are you not pregnant or on kidney dialysis?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't be undergoing any new or extra medical treatments. You'll be having the PCI heart procedure as planned, and the most important part of your involvement will be providing some additional blood and urine samples. These samples will be collected at specific times, likely around the time of your heart procedure. The research team will also review your existing medical records to gather relevant health information. All of this is part of observing your body's natural response to the procedure, with no special medications or extra visits beyond what your regular care would involve. The total duration of your participation will be clear from the start.

Potential risks and benefits

The main potential benefit of this study is that the findings could help future patients with diabetes by improving how we predict and prevent kidney problems related to heart procedures. For you specifically, there are no direct medical benefits, as there are no new treatments involved. The risks are very low, mainly associated with the minor discomfort and very small chance of bruising from the extra blood samples, similar to any routine blood test. 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.

The London Chest Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is a 'biomarker'?

A biomarker is simply something in your body, like a level in your blood or urine, that can give doctors clues about your health or a specific condition.

What procedures use a 'dye' that can affect kidneys?

Many X-ray procedures, especially those looking at your heart or blood vessels, use a special liquid 'dye' to make parts of your body show up more clearly on the images.

Will taking part in this study change my medical treatment?

No, taking part in this study will not change the medical care or treatment you receive for your diabetes or heart condition. You will receive your usual care as planned.

What is a PCI procedure?

PCI stands for Percutaneous Coronary Intervention. It's a common heart procedure used to open narrowed or blocked arteries (blood vessels) in the heart, often to treat angina or prevent a heart attack.

Will my information be kept private?

Yes, all your personal and medical information collected for the study will be kept strictly confidential and anonymous, meaning your name won't be linked to your results.

How to find out more

AKHIL KAPUR

akhil.kapur@bartsandthelondon.nhs.uk 0208 983 2413 Official trial record

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