Non-Alcoholic Fatty Liver DiseaseNCT04141592
Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease
An observational study of Non-Alcoholic Fatty Liver Disease, run by Queen Mary University of London at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Bariatric Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 153 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Mar 2019to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be identified from outpatient clinics of Bariatric, Gastroenterology, and Hepatology services at Homerton and King College Hospitals in addition to Gastroenterology outpatients from the Barts Health NHS Trust. Healthy control participants will be identified from patients undergoing outpatient assessment, gastroscopy or surgery for other non-malignant gastrointestinal disorders at hospital sites.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Homerton University Hospital Foundation Trust
London, Greater London, E9 6SR
Rosemary Mullett, +44208 510 5117, rosemary.mullett@nhs.net
About this study
Official title: Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease: Cross-sectional Comparative Study Between Patients and Healthy Controls
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
Read the detailed 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Bariatric Surgery
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric SurgeryProcedure or surgery
Also called Upper GI surgery
Already clinically indicated surgical procedures
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | non-obese individuals without fatty liver disease | |
| Obese wihtout non-alcoholic steatohepatitis | Body mass index greater than 30 without liver histological evidence of non-alcoholic fatty liver disease Receives: Procedure: Bariatric Surgery | |
| Obese Non-alcoholic steatohepatitis | Body mass index greater than 30 with liver histological evidence of non-alcoholic fatty liver disease Receives: Procedure: Bariatric Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of weight loss surgery upon Non-alcoholic steatohepatitis
Proportion of patients developing resolution of NASH after weight loss surgery
Measured: Two years
Secondary outcomes (1)
Impact of weight loss surgery upon Non-invasive measures of fibrosis
Evaluation of changes in liver transient elastography post weight loss surgery
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start5 Mar 2019
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Homerton University Hospital NHS Foundation Trust, Barts & The London NHS Trust, King's College Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- William Alazawi, MD Phd, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141592
- Sponsor's protocol ID
- 247449
- Status last verified
- Jun 2026
- First submitted
- 23 Oct 2019
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease: Cross-sectional Comparative Study Between Patients and Healthy Controls
- ClinicalTrials.gov ID
- NCT04141592
- Acronym / sponsor ID
- 247449
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Homerton University Hospital NHS Foundation Trust, Barts & The London NHS Trust, King's College Hospital NHS Trust
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | –non-obese individuals without fatty liver disease |
| Obese wihtout non-alcoholic steatohepatitis | – | Procedure: Bariatric SurgeryBody mass index greater than 30 without liver histological evidence of non-alcoholic fatty liver disease |
| Obese Non-alcoholic steatohepatitis | – | Procedure: Bariatric SurgeryBody mass index greater than 30 with liver histological evidence of non-alcoholic fatty liver disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be identified from outpatient clinics of Bariatric, Gastroenterology, and Hepatology services at Homerton and King College Hospitals in addition to Gastroenterology outpatients from the Barts Health NHS Trust. Healthy control participants will be identified from patients undergoing outpatient assessment, gastroscopy or surgery for other non-malignant gastrointestinal disorders at hospital sites.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric SurgeryAlso: Upper GI surgeryAlready clinically indicated surgical procedures | Procedure or surgery | Obese Non-alcoholic steatohepatitis, Obese wihtout non-alcoholic steatohepatitis |
Primary outcome
Impact of weight loss surgery upon Non-alcoholic steatohepatitis
Time frame: Two years
Proportion of patients developing resolution of NASH after weight loss surgery
1 secondary outcome
Impact of weight loss surgery upon Non-invasive measures of fibrosis
Time frame: Six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Alazawi, MD Phd principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Alazawi, MD Phd (+442078822308, w.alazawi@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of weight loss surgery upon Non-alcoholic steatohepatitis (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.