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Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease

Sponsor: Queen Mary University of London

NCT ID: NCT04141592

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Bariatric Surgery (procedure)
How long the study runs
Study runs about 88 months (dates as stated)
About the drug or intervention
Bariatric Surgery — procedure: Already clinically indicated surgical procedures
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
153
Started
2019-03-05
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for non-alcoholic fatty liver disease
  • • Clinical study - 153 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with non-alcoholic fatty liver disease

Where?

  • • London - Homerton University Hospital Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

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.

Non-Alcoholic Fatty Liver Disease

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Age ≥18 years
  • ✓Confirmed non-alcoholic Fatty liver disease (diagnosed clinically, radiologically or histologically)
  • ✓If diabetic, Diagnosed with Type 2 Diabetes Mellitus
  • ✓Healthy Control: no diagnosis of any liver condition including NAFLD
  • ✓o NAFLD excluded by Fibroscan Controlled Attenuation Parameter (CAP) score of \<222 dB/m

Who cannot take part

  • ✗Unwilling or unable to give agreement to take part
  • ✗Type 1 Diabetes Mellitus
  • ✗Other form of liver disease (other than NAFLD)
  • ✗o Viral hepatitis, Auto-immune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis,...
  • ✗Taking medication associated with liver dysfunction (except methotrexate)
See the full criteria
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 Is This Study? (1 UK site)

Homerton University Hospital Foundation Trust

London E9 6SR, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

William Alazawi, MD Phd

Sponsor contact

CONTACT

+442078822308 w.alazawi@qmul.ac.uk

James Brindley, Md Phd

Sponsor contact

CONTACT

+442078827198 james.brindley@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2026-06