Image

Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

Overview

To identify key characteristics of the tissue resident and peripherally circulating immune-phenotype in addition to blood markers, metabolic profile, faecal and oral microbiota in non-alcoholic fatty liver disease

Description

In this study, the investigators will collect tissue, blood, stool, urine and saliva samples at the same time in order to enable a comprehensive disease phenotyping and ability to compare immunological, microbiological and metabolic features in patients with varying stages of NAFLD and healthy controls. To date there are limited published data evaluating simultaneously-obtained samples from adipose, gut and liver tissue and peripheral blood in NAFLD. The majority of participants in this study will be recruited from the bariatric surgery services enabling multiple tissue samples to be collected at time of surgery with minimal additional risk to participants.

Eligibility

Inclusion Criteria:

  • Age ≥18 years
  • Confirmed non-alcoholic Fatty liver disease (diagnosed clinically, radiologically or histologically)
  • If diabetic, Diagnosed with Type 2 Diabetes Mellitus

OR

• Healthy Control: no diagnosis of any liver condition including NAFLD

  • NAFLD excluded by Fibroscan Controlled Attenuation Parameter (CAP) score of <222 dB/m

Exclusion Criteria:

  • Unwilling or unable to give informed consent
  • Type 1 Diabetes Mellitus
  • Other form of liver disease (other than NAFLD)
    • Viral hepatitis, Auto-immune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, haemochromatosis, Sarcoidosis, cystic fibrosis, sickle cell disease
  • Taking medication associated with liver dysfunction (except methotrexate)
  • Auto-immune disease which in the investigator's opinion may confound immune profiling
  • Concomitant immunosuppressive medications (except methotrexate, short course oral steroids or inhaled corticosteroids)
  • Currently pregnant
  • Any major organ transplant (excluding corneal or hair transplant)
  • Regular alcohol intake greater than 14 units a week for female participants and 21 units a week for male participants

Study details

Non-Alcoholic Fatty Liver Disease

NCT04141592

Queen Mary University of London

12 June 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.