Health TrialsbyHealthPanel

Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease

ConditionNon-Alcoholic Fatty Liver Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQueen Mary University of London

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Confirmed non-alcoholic Fatty liver disease (diagnosed clinically, radiologically or histologically)

If diabetic, Diagnosed with Type 2 Diabetes Mellitus

Disqualifiers

Unwilling or unable to give informed consent

Type 1 Diabetes Mellitus

Other form of liver disease (other than NAFLD)

Taking medication associated with liver dysfunction (except methotrexate)

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Bariatric Surgery

    Procedure/Surgery

    Already clinically indicated surgical procedures

Treatment groups

153 Participants
are divided into 3 treatment groups
Group A: Healthy Control0 interventions
Group B: Obese wihtout non-alcoholic steatohepatitis1 intervention
Group C: Obese Non-alcoholic steatohepatitis1 intervention

Trial outcomes

Primary outcomes

1

Impact of weight loss surgery upon Non-alcoholic steatohepatitis

Proportion of patients developing resolution of NASH after weight loss surgery

Time frame
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

Time frame
Six months

Other outcomes

Sponsors and contacts

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Queen Mary University of London

Lead sponsor

Homerton University Hospital NHS Foundation Trust

Collaborator

Barts & The London NHS Trust

Collaborator

King's College Hospital NHS Trust

Collaborator

Source ClinicalTrials.gov
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