Active not recruitingOBSERVATIONAL

MRI and Stable Isotope Tracer Studies for Detecting the Progression of Non-Alcoholic Steatohepatitis (NASH)

This study aims to understand why some people with non-alcoholic fatty liver disease (NAFLD) develop more serious conditions like liver inflammation or scarring. Scientists don't fully understand how this happens, so finding early warning signs is crucial. We're looking at how the body processes fats and the role of a substance called L-carnitine, which is important for fat metabolism and may be low in liver disease. We'll use special MRI scans and other tests that trace how the body uses food. Better understanding these changes could help doctors predict who is at risk and develop new ways to diagnose and treat these liver problems earlier.

At a glance

Status

Active not recruiting

Sponsor

University of Oxford

Enrolment target

Start

01 Mar 2020

Estimated completion

01 Oct 2027

Non-Alcoholic Fatty Liver Disease

What is this study about?

Many people have non-alcoholic fatty liver disease (NAFLD), where too much fat builds up in their liver. For some, this can get worse, leading to swelling, scarring, and even serious liver damage called cirrhosis. Right now, doctors don't fully understand why some people's NAFLD gets worse while others' doesn't. This makes it hard to know who needs early treatment.

This study hopes to shed light on how NAFLD progresses. We're especially interested in how your body handles fats and a natural substance called L-carnitine. L-carnitine is vital for your body to process fats, and some research suggests that people with liver disease might have lower levels of it. If we can understand these processes better, it might lead to new tests that can spot people at higher risk of their liver disease getting serious, so they can get help sooner.

We'll use special non-invasive methods like MRI scans to look at your liver and heart, which can tell us about their function and how they use energy. We'll also use 'stable isotope labelling' which involves giving you a safe, special type of food that helps us track how your body turns carbohydrates into fats. Another part of the study will involve looking at whether L-carnitine can be seen in the liver using MRI, which could help with future tests.

Key takeaways

The study aims to understand why NAFLD gets worse for some people.
It uses special MRI scans to look at the liver and heart.
Researchers are also interested in how your body handles fats and L-carnitine.
Participation involves either one or two visits, with scans and blood/breath tests.
This research could help develop better ways to detect and treat NAFLD early.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To take part in this study, you need to be at least 18 years old. We are looking for people who have different stages of non-alcoholic fatty liver disease (NAFLD). This includes those with early-stage fatty liver, those with inflammation and damage (NASH), and people with a more advanced stage called NASH cirrhosis. Your diagnosis will usually need to be confirmed by a liver biopsy or other medical tests.

We also need a small group of healthy people to help us understand how L-carnitine changes in the body. If you have severe allergies, especially to egg, or if you have certain medical conditions that mean you can't have an MRI scan, or a history of significant alcohol use, you would not be able to join. We will also ask about lactose intolerance and make adjustments if needed.

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 a diagnosis of Non-Alcoholic Fatty Liver Disease (NAFLD) in any stage?
Are you comfortable having an MRI scan?
Do you have any severe allergies, especially to egg ingredients?
Do you have a history of significant alcohol use?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll have either one or two study visits. For people with NAFLD, the first visit will involve special MRI scans of your liver and heart, which will take about three hours. The second visit, within two weeks of the first, will be a longer day (up to eight hours). During this day, you'll have some blood and breath tests before and after eating a special meal. This helps us track how your body processes fats.

For healthy volunteers, it's just one visit. You'll have an MRI scan, then receive an injection of L-carnitine, and have another MRI scan two hours later. This helps us see if the L-carnitine can be detected in your liver and heart using MRI. Throughout the study, we won't be giving you any special medications to treat your liver condition, but we will be observing how your body works.

Potential risks and benefits

Taking part in this study won't directly improve your liver condition. However, the information we learn could help many others in the future by improving diagnosis and treatment for NAFLD. Potential risks include the minor discomforts of blood tests, spending time in the MRI scanner (which is a contained space), and possible allergic reactions to the special food ingredient (egg in some cases if not lactose-intolerant, which will be discussed fully). You are free to withdraw from the study at any time without giving a reason, and your medical care will not be affected.

Locations (1)

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

University of Oxford
Verified postcode
Oxford, United Kingdom

Common questions

What is Non-Alcoholic Fatty Liver Disease (NAFLD)?

It's a condition where too much fat builds up in your liver, not caused by drinking alcohol. For some, it can lead to more serious liver problems.

What is L-carnitine?

L-carnitine is a substance your body naturally makes. It's important for helping your body turn fats into energy.

What is an MRI scan?

An MRI scan uses strong magnets and radio waves to create detailed pictures of the inside of your body. It doesn't use X-rays.

Will I have to eat anything special?

Yes, if you have NAFLD, you'll have a special, safe test meal during one of your visits. This helps us track how your body processes food.

Will I get my test results?

The study collects information for research purposes. While we can't provide individual results for research tests, findings relevant to your health would be shared with your GP.