Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04141592
• Other study ID #: 247449
• Status: Recruiting
• Start date: February 19, 2019
• Est. completion date: December 29, 2023

Study information

• Verified date: January 2023
• Source: Queen Mary University of London
• Contact: William Alazawi, MD Phd
• Phone: +442078822308
• Email: w.alazawi[@]qmul.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 153
• Est. completion date: December 29, 2023
• Est. primary completion date: September 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Procedure:
• Bariatric Surgery
Already clinically indicated surgical procedures

Locations

Country	Name	City	State
United Kingdom	Homerton University Hospital Foundation Trust	London	Greater London

Sponsors (4)

Lead Sponsor	Collaborator
Queen Mary University of London	Barts & The London NHS Trust, Homerton University Hospital NHS Foundation Trust, King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of weight loss surgery upon Non-alcoholic steatohepatitis	Proportion of patients developing resolution of NASH after weight loss surgery	Two years
Secondary	Impact of weight loss surgery upon Non-invasive measures of fibrosis	Evaluation of changes in liver transient elastography post weight loss surgery	Six months