RecruitingOBSERVATIONAL

Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease

This research is investigating Non-Alcoholic Fatty Liver Disease (NAFLD). NAFLD is a condition where too much fat builds up in the liver. We want to find out what makes this disease tick by looking closely at various parts of your body. We'll be studying immune cells, gut bacteria, and how your body uses energy (metabolism) in people with NAFLD compared to healthy individuals. We're particularly interested in how these factors change at different stages of the disease. Many participants will be people already having weight-loss surgery, which allows us to collect important samples like liver tissue with minimal extra risk.

At a glance

Status

Recruiting

Sponsor

Queen Mary University of London

Enrolment target

153

Start

05 Mar 2019

Estimated completion

01 Apr 2026

Non-Alcoholic Fatty Liver Disease

What is this study about?

This study is all about understanding Non-Alcoholic Fatty Liver Disease, commonly known as NAFLD. This is a condition where fatty deposits build up in the liver, which can sometimes lead to more serious liver problems over time. Even though it's quite common, we still have a lot to learn about why some people get it, why it progresses in some and not others, and how best to treat it.

Our research team wants to get a much clearer picture of what's happening inside the bodies of people with NAFLD. We're going to be looking at several things that are thought to play a role: your immune system (how your body fights off illness), the bacteria living in your gut and mouth, and your body's metabolism (how it turns food into energy). By studying these different areas at the same time, we hope to find key features that can help us understand the disease better and potentially lead to new ways to diagnose or treat it in the future.

To do this, we'll be collecting different types of samples from volunteers, including small pieces of tissue, blood, stool (poo), urine, and saliva. Many of our volunteers will be people who are already scheduled for weight-loss surgery. This is important because it allows us to collect samples like liver tissue during their planned surgery, which means participants don't need to undergo extra procedures just for the study, making it safer and more convenient for them. By comparing these samples from people with different stages of NAFLD and healthy volunteers, we aim to uncover vital clues about this condition.

Key takeaways

This study aims to understand Non-Alcoholic Fatty Liver Disease (NAFLD) in detail.
Researchers will collect various samples (blood, tissue, stool, urine, saliva) to study immune systems, gut bacteria, and metabolism.
The goal is to discover new ways to diagnose and treat NAFLD.
Many participants will be people undergoing weight-loss surgery, making sample collection safer.
Participation involves providing samples at one time point; no long-term follow-up.
The study promises potential future benefits for NAFLD patients, rather than direct benefits to participants.

Who may be eligible?

To join this study, you need to be 18 years or older. You should have Non-Alcoholic Fatty Liver Disease (NAFLD)diagnosed by your doctor, or through scans or biopsies. If you have Type 2 Diabetes, you can still participate.

We are also looking for healthy volunteers who do not have any liver conditions, including NAFLD. For healthy volunteers, we will check that you don't have NAFLD using a special scan called a Fibroscan.

There are some reasons why you might not be able to join. These include having Type 1 Diabetes, other types of liver disease (like Hepatitis or autoimmune liver conditions), or if you are taking certain medications that affect your liver or immune system. We also can't include you if you're pregnant, have had a major organ transplant (other than eye or hair transplants), or if you drink more than 14 units of alcohol a week for women or 21 units for men.

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)? (Or are you a healthy person with no liver conditions?)
Are you able to give your consent to take part?
Do you have Type 1 Diabetes, or any other liver disease apart from NAFLD?
Are you pregnant or plan to become pregnant during the study period?
Do you drink more than 14 units of alcohol per week if female, or 21 units if male?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, we will ask you to provide several samples. These include blood samples, stool (poo) samples, urine samples, saliva samples, and if you are having weight-loss surgery, small tissue samples from your liver and fat. All these samples will be collected at one time point.

There are no specific medications you need to take or avoid for this study, apart from certain types that might exclude you from participating. There's no long-term follow-up required after your initial sample collection. The total duration of your active involvement will be limited to the time it takes to provide all the necessary samples during one visit or during your scheduled surgery.

Potential risks and benefits

Participating in this study might not directly benefit your health, but the information we gather will help us better understand NAFLD, which could lead to improved treatments for others in the future. The risks involved are generally low, mainly related to blood draws (like slight bruising or discomfort) and any risks associated with providing tissue samples during planned surgery, which are already part of your surgical procedure. You have the right to withdraw from the study at any time without giving a reason, and this 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.

Homerton University Hospital Foundation Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is NAFLD?

NAFLD stands for Non-Alcoholic Fatty Liver Disease. It means too much fat has built up in your liver, but it's not caused by drinking too much alcohol.

Why do you need so many different samples?

By looking at samples like blood, tissue, and stool, we can get a full picture of how your immune system, gut bacteria, and metabolism are all connected and involved in NAFLD.

Is the study just for people having surgery?

No, we are also looking for people with NAFLD who are not having surgery, and healthy volunteers. However, many participants with NAFLD will be recruited from surgical clinics to make tissue collection easier and safer.

Will I get any results back from my samples?

No, you will not receive individual results from your samples. The results will be analysed as a group to help us understand NAFLD generally.

How long will I be involved in the study?

Your direct involvement will be for a single visit or during your scheduled surgery, when all the samples will be collected. There is no long-term follow-up.

How to find out more

William Alazawi, MD Phd

w.alazawi@qmul.ac.uk +442078822308 Official trial record

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