RecruitingOBSERVATIONAL

The European NAFLD Registry

This large European study is focused on non-alcoholic fatty liver disease (NAFLD) and a more serious form called NASH. Doctors and scientists are gathering a lot of information and samples from people with NAFLD to learn more about how the disease affects different people, how it develops over time, and what causes it. The main goal is to find better tests and ways to keep an eye on the disease's progression, from simple fatty liver to more advanced stages like fibrosis (scarring of the liver). This research could help doctors understand who is at higher risk and how to manage the condition more effectively in the future. It's an observational study, meaning patients are monitored without receiving new treatments as part of the study.

At a glance

Status

Recruiting

Sponsor

Newcastle University

Enrolment target

10,000

Start

01 May 2015

Estimated completion

31 Dec 2030

NAFLD NASH NASH - Nonalcoholic Steatohepatitis Fibrosis, Liver Steatosis of Liver Hepatocellular Carcinoma Cardiovascular Diseases Type 2 Diabetes Dyslipidaemia Hypertension Obesity Other Associated Comorbidities

What is this study about?

Imagine a big European effort to understand a common but often misunderstood liver problem called non-alcoholic fatty liver disease (NAFLD). This happens when too much fat builds up in the liver, not because of drinking alcohol, but often linked to conditions like obesity, type 2 diabetes, and high blood pressure. Sometimes, NAFLD can get worse and lead to a more serious type of liver inflammation called NASH, which can cause scarring (fibrosis) and even more severe liver damage.

This study, called The European NAFLD Registry, is like a large information gathering project. Doctors and researchers across many universities in Europe are working together to collect detailed information and samples from thousands of people who have NAFLD. They're looking at things like your medical history, any other health conditions you have, the medications you take, and results from blood tests, scans, and sometimes even liver biopsies. They also collect biological samples like blood, urine, and even stool.

The main idea is to create a huge database that can help them understand why some people's NAFLD stays mild, while for others it gets worse and develops into NASH or more serious scarring. By putting all this information together, they hope to discover new 'markers' – like clues in your blood or other samples – that could help doctors detect NAFLD and its progression earlier and more accurately. This could lead to better ways to diagnose, monitor, and potentially treat the disease in the future, improving health for many people.

Key takeaways

It's a large European study researching non-alcoholic fatty liver disease (NAFLD).
It's an 'observational' study, meaning no new treatments are given.
The goal is to understand NAFLD better and find new ways to detect and monitor it.
Information and samples (like blood, urine, and sometimes liver tissue) are collected.
Your participation helps improve future care for people with NAFLD.
You can withdraw at any time without affecting your medical treatment.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. The doctors must suspect you have non-alcoholic fatty liver disease (NAFLD). This suspicion might come from a past liver biopsy showing NAFLD, having a liver biopsy planned for possible NAFLD with other consistent test results, or having signs of liver scarring (cirrhosis) along with at least two conditions linked to metabolic syndrome, such as a large waistline, being overweight, having high blood sugar or type 2 diabetes, high cholesterol, or high blood pressure.

It's important that your average alcohol consumption has been low – less than 21 units per week for men and less than 14 units per week for women – over the past six months, and you haven't had a history of drinking too much alcohol over the last five years. These limits are roughly equivalent to about 10-11 standard glasses of wine for men and 7 for women each week. This helps ensure that alcohol is not the cause of your liver condition.

You would not be able to join if you cannot give your informed consent, if you drink more alcohol than the limits mentioned, if you have type 1 diabetes, or other types of chronic liver disease not related to NAFLD. Also, if you've recently taken certain medications known to affect the liver (like some steroids or specific drugs for other conditions) or have reasons not to have a liver biopsy, you wouldn't be suitable for this study.

Quick self-check

Are you 18 years old or older?
Has your doctor told you that they suspect you have NAFLD?
Do you drink less than 21 units of alcohol per week if you're a man, or 14 units if you're a woman, and haven't had a history of heavy drinking?
Do you *not* have type 1 diabetes or another type of chronic liver disease (other than NAFLD)?
Are you able to provide your informed consent to take part?

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 in this study, you won't be given any new experimental treatments. Instead, this is an 'observational' study. This means doctors will collect information from you over time, usually during your regular visits to liver or diabetes clinics, or if you're undergoing weight-loss (bariatric) surgery. They will gather data like your medical history, details about your health conditions, the medications you're taking, and results from your standard blood tests and scans.

They will also ask for samples, including blood, urine, and sometimes stool. If you've had a liver biopsy or are having one, they might also ask to use a small sample of your liver tissue for research. You might also be invited to take part in extra, related studies, like one that looks at advanced liver scans, but you would need to agree to these separately. The exact number of visits and the total duration would depend on your individual medical care and the specific follow-up needed for the study, but it works alongside your existing appointments. The information and samples collected will be used to understand NAFLD better and develop new diagnostic tools.

Potential risks and benefits

Participating in this study might not directly benefit your health right away, as it's an observational study and you won't receive new treatments. However, your contribution is incredibly valuable because it will help researchers learn more about NAFLD, which could lead to better understanding, diagnosis, and treatment for other patients in the future. The risks involved are generally low, mainly related to the standard medical procedures you might already undergo, such as having blood tests or providing other samples. Any procedures beyond your usual care would be fully explained before you agree. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (37)

Universitair Ziekenhuis Antwerpen
Antwerp, Belgium· Recruiting
Helsinki University Hospital
Helsinki, Finland· Recruiting
Le Centre de Recherche Clinique (CRC) du CHU d'Angers
Angers, France· Recruiting
Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière
Paris, France· Recruiting
UNIVERSITÄTSKLINIKUM der RWTH Aachen
Aachen, Germany· Not yet recruiting
Charité University Hospital Berlin
Berlin, Germany· Not yet recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany· Not yet recruiting
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz
Mainz, Germany· Recruiting
Universitätsklinikums Würzburg
Würzburg, Germany· Recruiting
Laiko General Hospital of Athens
Athens, Greece· Recruiting
Polytechnic University of Marche
Ancona, Italy· Recruiting
Università degli Studi Milano
Milan, Italy· Recruiting

+25 more sites — see the official record for the full list.

Common questions

What is NAFLD?

NAFLD stands for non-alcoholic fatty liver disease. It means there's too much fat in your liver, but it's not caused by drinking alcohol. It's often linked to being overweight, type 2 diabetes, and high blood pressure.

Will I get new medicine in this study?

No, this study is 'observational', meaning you won't be given new medicines or treatments as part of it. Researchers will just collect information and samples as part of your usual care.

What kind of information will you collect about me?

The study will collect details about your health, medical history, medicines you take, and results from blood tests, scans, and sometimes tissue samples, all to understand NAFLD better.

How long will I be in the study?

The study collects information over time, often during your regular hospital visits. The exact duration depends on your individual involvement and ongoing medical care.

Can I leave the study if I change my mind?

Yes, you can leave the study at any point, and it won't affect the medical care you receive from your doctors.

How to find out more

Quentin M Anstee, MBBS, PhD

quentin.anstee@ncl.ac.uk +44(0)191 20 87012 Official trial record

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