Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease
Recruiting · NCT04141592 · Observational (researchers observe without assigning treatment) · Lead sponsor: Queen Mary University of London
View the official record on ClinicalTrials.gov →Interventions studied
Bariatric Surgery
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
- 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)
- 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
Where it is running
1 location listed.
- Homerton University Hospital Foundation Trust - London, Greater London, United Kingdom