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Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease

Sponsor
Queen Mary University of London (Other)
Overall Status
Recruiting
CT.gov ID
NCT04141592
Collaborator
Homerton University Hospital NHS Foundation Trust (Other), Barts & The London NHS Trust (Other), King's College Hospital NHS Trust (Other)
153
Enrollment
1
Location
54.5
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bariatric Surgery

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

Study Type:
Observational
Anticipated Enrollment :
153 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease: Cross-sectional Comparative Study Between Patients and Healthy Controls
Actual Study Start Date :
Feb 19, 2019
Anticipated Primary Completion Date :
Feb 5, 2023
Anticipated Study Completion Date :
Sep 5, 2023

Arms and Interventions

Arm Intervention/Treatment
Healthy Control

non-obese individuals without fatty liver disease
Non-alcoholic fatty liver disease without NASH

Procedure: Bariatric Surgery
Already clinically indicated surgical procedures
Other Names:
  • Upper GI surgery

    		•
    Non-alcoholic steatohepatitis

    Procedure: Bariatric Surgery
    Already clinically indicated surgical procedures
    Other Names:
  • Upper GI surgery

    		•
    Obese without non-alcoholic fatty liver disease

    Procedure: Bariatric Surgery
    Already clinically indicated surgical procedures
    Other Names:
  • Upper GI surgery

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Impact of weight loss surgery upon Non-alcoholic steatohepatitis [Two years]

      Proportion of patients developing resolution of NASH after weight loss surgery

    Secondary Outcome Measures

    1. Impact of weight loss surgery upon Non-invasive measures of fibrosis [Six months]

      Evaluation of changes in liver transient elastography post weight loss surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Homerton University Hospital Foundation Trust London Greater London United Kingdom E9 6SR

    Sponsors and Collaborators

    • Queen Mary University of London
    • Homerton University Hospital NHS Foundation Trust
    • Barts & The London NHS Trust
    • King's College Hospital NHS Trust

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Queen Mary University of London
    ClinicalTrials.gov Identifier:
    NCT04141592
    Other Study ID Numbers:
    • 247449
    First Posted:
    Oct 28, 2019
    Last Update Posted:
    Dec 9, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Diseases
    Fatty Liver
    Non-alcoholic Fatty Liver Disease

    Study Results

    No Results Posted as of Dec 9, 2021