RecruitingOBSERVATIONAL

Development of a Non-invasive Screening Tool to Predict Metabolic Dysfunction-associated Steatotic Liver Disease

This research is focused on developing an easy-to-use screening tool for a common liver condition called Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), previously known as non-alcoholic fatty liver disease. This condition affects about one in four people in the UK and can sometimes lead to serious liver problems. Currently, finding MASLD often involves invasive tests. We want to find a gentler way to identify it. We're inviting up to 2,000 volunteers, including healthy individuals and those already diagnosed with MASLD, to help us. During a single visit, we'll collect blood samples, measure your body, take your medical history, and perform some non-invasive scans. We’ll then use this information to create a scoring system that can accurately predict MASLD using simple, non-invasive methods.

At a glance

Status

Recruiting

Sponsor

Richmond Research Institute

Enrolment target

2,000

Start

27 Sep 2019

Estimated completion

31 Dec 2027

Healthy Fatty Liver MASLD MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease Obesity and Obesity-related Medical Conditions

What is this study about?

Fatty liver disease, now often called Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), is a very common condition affecting about one in four people in the UK. Many people don't even know they have it. While it often doesn't cause immediate problems, in some cases it can lead to more serious liver issues, such as inflammation, scarring (cirrhosis), and even liver cancer over time. This can also make it difficult for people with undiagnosed MASLD to take part in new drug trials, as abnormal liver tests might prevent them from joining or even lead to them dropping out.

Currently, diagnosing fatty liver disease can sometimes require invasive procedures. The main goal of this study is to develop a simpler, less invasive way to identify MASLD. We want to create a special scoring system that can accurately predict whether someone has fatty liver disease using information we gather from easy tests, without needing a liver biopsy, for example.

By finding a non-invasive way to identify MASLD, we hope to make it easier for people to be screened for the condition earlier. This could lead to better management and potentially prevent more serious liver problems down the line. It could also help improve future clinical trials by ensuring volunteers are correctly screened for underlying conditions that might affect their participation.

Key takeaways

Aims to create a simple way to detect common fatty liver disease (MASLD).
Looks at healthy people and those already diagnosed with MASLD.
Participation involves a single visit for blood tests, body measurements, and non-invasive scans (ultrasound, Fibroscan).
No medication or invasive procedures are involved.
Helps advance understanding and future diagnosis of MASLD.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you need to be a man or woman between 18 and 80 years old. You must be willing to understand and sign a consent form, and able to follow all the study instructions.

If you are joining 'Part B' of the study, you will also need to have a confirmed diagnosis of MASLD, either from your GP records or from a past liver scan (like a Fibroscan or ultrasound) that showed MASLD.

However, you won't be able to join if you have known alcoholic liver disease, or if you have severe scarring of the liver (cirrhosis) from any cause. You also can't take part if you have a history of serious liver problems like liver cancer. Drinking more than 30 units of alcohol per week, or having certain implanted heart devices, would also mean you are not eligible.

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 80 years old?
Are you willing to sign a consent form and follow study instructions?
Do you consume less than 30 units of alcohol per week?
Do you NOT have serious liver conditions like alcoholic liver disease or cirrhosis?
Do you NOT have an implanted cardiac (heart) device?
If interested in Part B, do you have a confirmed diagnosis of MASLD?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll need to attend our unit for one day. First, a study doctor will explain everything, and if you're happy to proceed, you'll sign a consent form. We will then take some blood samples and measure your body, including your weight, height, and waist size. The doctor will also ask about your medical history and perform a physical check-up.

Next, we'll use a special device called an ACUNIQ to measure your body composition – this is a simple, non-invasive test. Finally, you'll have an ultrasound scan of your liver and a Fibroscan, which is another type of scan that checks liver stiffness. Once all these assessments are complete, you can leave. There will be no further visits or follow-up required after this one-day assessment.

Potential risks and benefits

By taking part, you'll be contributing to important research that could lead to a simpler way to diagnose MASLD, potentially benefiting many people in the future. The tests involved, such as blood draws and scans, are generally safe, but there's a small risk of minor bruising or discomfort from blood tests. There are no direct personal benefits from participating, as we are creating a tool, not treating a condition. You are free to withdraw from the study at any time without giving a reason, and your decision will not affect your medical care.

Locations (1)

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

Richmond Pharmacology Ltd. 1a Newcomen St, London Bridge
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is MASLD?

MASLD stands for Metabolic Dysfunction-associated Steatotic Liver Disease. It's a common condition where too much fat builds up in the liver, often linked to weight and lifestyle, and can sometimes lead to liver damage.

What is a 'non-invasive screening tool'?

This means we're trying to find a simple way to check for MASLD without needing uncomfortable or risky procedures like a liver biopsy. Think of it as a gentler way to look for the condition.

Will I find out if I have MASLD?

This study is focused on developing a scoring tool, not on providing individual diagnoses. We will not be giving out personal results from the tests performed during the study.

How long will the study visit take?

All the assessments will be done in a single visit on one day. We expect it to take a few hours to complete all the tests.

Will I be given any medication as part of the study?

No, this study is purely observational, meaning we're gathering information. You will not be given any new medications or treatments as part of your participation.

How to find out more

James Rickard

grants@richmondresearchinstitute.org +44 (0)20 7042 5800 Official trial record

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