Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease

Recruiting

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Procedure: Bariatric Surgery

• Registration Number: NCT04141592
• Lead Sponsor: Queen Mary University of London

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

Detailed 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.

Study Timeline

• Study Start: 2019-03-05
• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese wihtout non-alcoholic steatohepatitis	Bariatric Surgery	Body mass index greater than 30 without liver histological evidence of non-alcoholic fatty liver disease
Obese Non-alcoholic steatohepatitis	Bariatric Surgery	Body mass index greater than 30 with liver histological evidence of non-alcoholic fatty liver disease

Primary Outcome Measures

Name	Time	Method
Impact of weight loss surgery upon Non-alcoholic steatohepatitis	Two years	Proportion of patients developing resolution of NASH after weight loss surgery

Secondary Outcome Measures

Name	Time	Method
Impact of weight loss surgery upon Non-invasive measures of fibrosis	Six months	Evaluation of changes in liver transient elastography post weight loss surgery

Trial Locations

Locations (1)

Homerton University Hospital Foundation Trust; 🇬🇧 London, Greater London, United Kingdom