Investigating immune and metabolic features in non-alcoholic fatty liver disease
Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease: Cross-sectional Comparative Study Between Patients and Healthy Controls
This study is trying to learn more about the immune and metabolic features of non-alcoholic fatty liver disease by collecting samples from patients at different stages of the disease and comparing them to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 153 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Queen Mary University of London Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (London, Greater London) |
| Trial ID | NCT04141592 on ClinicalTrials.gov |
What this trial studies
This study aims to identify key characteristics of immune-phenotypes and metabolic profiles in patients with non-alcoholic fatty liver disease (NAFLD) by collecting tissue, blood, stool, urine, and saliva samples simultaneously. The research will compare these features across different stages of NAFLD and healthy controls, providing a comprehensive disease phenotyping. Most participants will be recruited from bariatric surgery services, allowing for the collection of multiple tissue samples with minimal additional risk. This approach addresses the limited data available on simultaneous sample collection from various tissues in NAFLD.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed non-alcoholic fatty liver disease or healthy controls without any liver conditions.
Not a fit: Patients with other liver diseases, Type 1 Diabetes Mellitus, or those taking medications associated with liver dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of NAFLD and lead to improved diagnostic and therapeutic strategies for patients.
How similar studies have performed: While there is limited published data on simultaneous sample collection in NAFLD, this approach is innovative and may provide new insights into the disease.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London, Greater London
- Homerton University Hospital Foundation Trust — London, Greater London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: William Alazawi, MD Phd — Queen Mary University of London
- Study coordinator: William Alazawi, MD Phd
- Email: w.alazawi@qmul.ac.uk
- Phone: +442078822308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.