Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bariatric Surgery.
- Who it may be relevant to
- Registry conditions: Non-Alcoholic Fatty Liver Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease: Cross-sectional Comparative Study Between Patients and Healthy Controls
Overview
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.
Interventions
- Procedure Bariatric Surgery
Already clinically indicated surgical procedures
Primary outcome measures
- Impact of weight loss surgery upon Non-alcoholic steatohepatitis [Time frame: Two years]
Secondary outcome measures (1)
- Impact of weight loss surgery upon Non-invasive measures of fibrosis [Time frame: Six months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United Kingdom · 1 center
- Homerton University Hospital Foundation Trust — London
Identifiers
NCT: NCT04141592 · 247449