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NCT Number: NCT04141592

Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Homerton University Hospital Foundation Trust

London, Greater London, E9 6SR, United Kingdom

Location status: Recruiting

Location contact

Rosemary Mullett

CONTACT

[email protected]

+44208 510 5117

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

Procedure

Already clinically indicated surgical procedures

Other names: Upper GI surgery

Primary outcomes

  1. Impact of weight loss surgery upon Non-alcoholic steatohepatitis

    Time frame: Two years

    Proportion of patients developing resolution of NASH after weight loss surgery

Secondary outcomes

  1. Impact of weight loss surgery upon Non-invasive measures of fibrosis

    Time frame: Six months

    Evaluation of changes in liver transient elastography post weight loss surgery

Study contacts

Contact information is provided by the study sponsor or research team.

James Brindley, Md Phd

CONTACT

[email protected]

+442078827198

William Alazawi, MD Phd

CONTACT

[email protected]

+442078822308

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Collaborators

  • Barts & The London NHS Trust
  • Homerton University Hospital NHS Foundation Trust
  • King's College Hospital NHS Trust

Registry information

Official study title

Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease: Cross-sectional Comparative Study Between Patients and Healthy Controls

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Oct 28, 2019
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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