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Investigating Pathological Mechanisms In Non-Alcoholic Fatty Liver Disease Cross-Sectional Comparative Study Between Patients And Healthy Controls
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Age: 18 Years +
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ID04141592
Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease
Cross-sectional Comparative Study Between Patients and Healthy Controls
Led by Queen Mary University of London
Updated on 2026-06-05
Participants Needed: 153
Research Sites: 1
Total Duration: N/A
On this page
- AI-Summary
- Brief Title
- Who Can Participate
- AI-Screening
- Your Study Journey
- Trial Site Locations
- Research Team
- How is the study designed?
- Similar Trials
- Frequently Asked Questions
- Sponsors
AI-Summary
What This Trial Is About
Researchers are investigating the characteristics of immune cells, blood markers, metabolic profiles, and microbiota in people with non-alcoholic fatty liver disease (NAFLD) compared to healthy individuals. The study aims to better understand the disease by analyzing samples from different body tissues and fluids, including blood, stool, urine, saliva, and tissue from fat, gut, and liver. This research is observational and includes participants with different stages of NAFLD as well as healthy controls. Participants will be grouped as healthy controls without fatty liver disease, obese individuals without liver evidence of NAFLD, and obese individuals with confirmed NAFLD. Most participants will be recruited from bariatric surgery services, allowing collection of multiple tissue samples during surgery with minimal extra risk. The study will observe the impact of weight loss surgery on non-alcoholic steatohepatitis over two years and assess changes in liver fibrosis measures within six months. During the study, participants will provide tissue, blood, stool, urine, and saliva samples at the same time for comprehensive disease profiling. Researchers will monitor immune, microbiological, and metabolic features across participant groups. Outcomes include the effect of weight loss surgery on liver inflammation and fibrosis. The study runs over two years, with regular assessments and sample collections to track changes and gather detailed information on NAFLD progression and treatment effects.
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Brief Title
Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease
Who Can Participate
Age: 18 Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed non-alcoholic fatty liver disease diagnosed clinically, radiologically, or histologically
- If diabetic, diagnosed with Type 2 Diabetes Mellitus
- Healthy controls with no liver condition including NAFLD
- NAFLD excluded in healthy controls by Fibroscan Controlled Attenuation Parameter (CAP) score below 222 dB/m
You will not qualify if you...
- Unwilling or unable to give informed consent
- Type 1 Diabetes Mellitus
- Other liver diseases besides NAFLD such as viral hepatitis, autoimmune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, haemochromatosis, sarcoidosis, cystic fibrosis, or sickle cell disease
- Taking medications associated with liver dysfunction except methotrexate
- Autoimmune diseases that may affect immune profiling
- Use of immunosuppressive medications except methotrexate, short course oral steroids, or inhaled corticosteroids
- Currently pregnant
- History of major organ transplant except corneal or hair transplant
- Regular alcohol intake exceeding 14 units per week for females or 21 units per week for males
AI-Screening
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Your Study Journey
Screening
Duration: 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration: At time of bariatric surgery or scheduled sample collection
Participants provide tissue, blood, stool, urine, and saliva samples for comprehensive disease phenotyping and comparison between patients and healthy controls.
1 visit during bariatric surgery for tissue collection; additional sample collections may occur depending on participant group
Long-term Monitoring
Duration: Up to 2 years
Participants are followed to observe the impact of weight loss surgery on non-alcoholic steatohepatitis and fibrosis using non-invasive measures.
Follow-up visits up to 2 years post-surgery
Trial Site Locations
Total: 1 location
- Homerton University Hospital Foundation Trust
London, Greater London, United Kingdom, E9 6SR
Actively Recruiting
Research Team
- William Alazawi, MD Phd
- James Brindley, Md Phd
How is the study designed?
Study Type: OBSERVATIONAL
Masking: N/A
Allocation: N/A
Model: N/A
Primary Purpose: N/A
Number of Arms: 3
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Sponsors
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Q Queen Mary University of London
Lead Sponsor
-
H Homerton University Hospital NHS Foundation Trust
Collaborating Sponsor
-
B Barts & The London NHS Trust
Collaborating Sponsor
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