Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease

NCT04141592 | Recruiting

• 1 other identifier: 247449
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Impact of weight loss surgery upon Non-alcoholic steatohepatitis

  Proportion of patients developing resolution of NASH after weight loss surgery

  Two years

Secondary Outcomes (1)

• Impact of weight loss surgery upon Non-invasive measures of fibrosis

  Six months

Study Arms (3)

Healthy Control

non-obese individuals without fatty liver disease

Obese wihtout non-alcoholic steatohepatitis

Body mass index greater than 30 without liver histological evidence of non-alcoholic fatty liver disease

Procedure: Bariatric Surgery

Obese Non-alcoholic steatohepatitis

Body mass index greater than 30 with liver histological evidence of non-alcoholic fatty liver disease

Procedure: Bariatric Surgery

Interventions

Bariatric Surgery PROCEDURE

Already clinically indicated surgical procedures

Also known as: Upper GI surgery

Obese Non-alcoholic steatohepatitis; Obese wihtout non-alcoholic steatohepatitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be identified from outpatient clinics of Bariatric, Gastroenterology, and Hepatology services at Homerton and King College Hospitals in addition to Gastroenterology outpatients from the Barts Health NHS Trust. Healthy control participants will be identified from patients undergoing outpatient assessment, gastroscopy or surgery for other non-malignant gastrointestinal disorders at hospital sites.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary University of London: lead
• Homerton University Hospital NHS Foundation Trust: collaborator
• Barts & The London NHS Trust: collaborator
• King's College Hospital NHS Trust: collaborator

Study Sites (1)

Homerton University Hospital Foundation Trust

London, Greater London, E9 6SR, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

PBMCs, serum, plasma, liver tissue

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• William Alazawi, MD Phd

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Alazawi, MD Phd

CONTACT

+442078822308; w.alazawi@qmul.ac.uk

James Brindley, Md Phd

CONTACT

+442078827198; james.brindley@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 28, 2019
• Study Start: March 5, 2019
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)