Investigating immune and metabolic features in non-alcoholic fatty liver disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to identify key characteristics of immune-phenotypes and metabolic profiles in patients with non-alcoholic fatty liver disease (NAFLD) by collecting tissue, blood, stool, urine, and saliva samples simultaneously. The research will compare these features across different stages of NAFLD and healthy controls, providing a comprehensive disease phenotyping. Most participants will be recruited from bariatric surgery services, allowing for the collection of multiple tissue samples with minimal additional risk. This approach addresses the limited data available on simultaneous sample collection from various tissues in NAFLD.

Why it matters

Who can join: the full rules

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

o 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)

  o 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

Where it's running

• Homerton University Hospital Foundation Trust
  London, Greater London, United Kingdom Recruiting

Study contacts

• Principal investigator: William Alazawi, MD Phd — Queen Mary University of London
• Study coordinator: William Alazawi, MD Phd
• Email: w.alazawi@qmul.ac.uk
• Phone: +442078822308

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Additive Physical Activity for Hypothyroidism in Older Women with Glaucoma and Fatty Liver

  We’re testing whether adding a treadmill-based exercise program to standard thyroid treatment helps improve health in older women who have subclinical hypothyroidism, glaucoma, and fatty liver.

  Recruiting Cairo University · Dokki, Giza Governorate · NCT07599241

• Lowering insulin to reduce liver fat production

  This study will try a short course of diazoxide to lower insulin and see if it reduces the liver's creation of new fat in adults with obesity, insulin resistance, and MASLD.

  Recruiting Phase 1 Columbia University · New York, New York · NCT07403604

• Efimosfermin alfa for adults with liver impairment

  This trial will test a single dose of efimosfermin alfa in adults with cirrhosis-related hepatic impairment from steatotic liver disease, with and without significant alcohol use, to measure drug levels and safety.

  Recruiting at 5 sites Phase 1 GlaxoSmithKline · Rialto, California and 4 other locations · NCT07358546

• Efimosfermin alfa for adults with biopsy-confirmed F2 or F3 MASH

  This trial will test whether efimosfermin alfa can resolve steatohepatitis and improve liver-related outcomes in adults with biopsy-confirmed F2 or F3 MASH.

  Recruiting at 91 sites Phase 3 GlaxoSmithKline · Chandler, Arizona and 90 other locations · NCT07221227

• Efimosfermin alfa injections for adults with F2–F3 MASH

  This study tests whether efimosfermin alfa injections are safe and tolerable for adults (18–75) with known or suspected metabolic dysfunction-associated steatohepatitis (MASH) and F2–F3 fibrosis.

  Recruiting at 66 sites Phase 3 GlaxoSmithKline · Arcadia, California and 65 other locations · NCT07221188

• Mediterranean diet with or without aerobic exercise for women with familial Mediterranean fever and fatty liver

  This trial will test whether adding regular aerobic exercise to a Mediterranean diet helps women with familial Mediterranean fever who have non-alcoholic fatty liver disease.

  Recruiting Cairo University · Dokki, Giza Governorate · NCT07130318

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.