RecruitingNCT04141592

Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease

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

Sponsor

Queen Mary University of London

Enrollment

153 participants

Start Date

Mar 5, 2019

Study Type

OBSERVATIONAL

Conditions

Non-Alcoholic Fatty Liver Disease

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

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria10

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