Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-05

Study Completion Date

2026-04-01

Brief Summary

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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

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Detailed Description

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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

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Non-Alcoholic Fatty Liver Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Control

non-obese individuals without fatty liver disease

No interventions assigned to this group

Obese wihtout non-alcoholic steatohepatitis

Body mass index greater than 30 without liver histological evidence of non-alcoholic fatty liver disease

Bariatric Surgery

Intervention Type PROCEDURE

Already clinically indicated surgical procedures

Obese Non-alcoholic steatohepatitis

Body mass index greater than 30 with liver histological evidence of non-alcoholic fatty liver disease

Bariatric Surgery

Intervention Type PROCEDURE

Already clinically indicated surgical procedures

Interventions

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Bariatric Surgery

Already clinically indicated surgical procedures

Intervention Type PROCEDURE

Other Intervention Names

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Upper GI surgery

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No