PANASH: Psoriasis and Non Alcoholic Steatohepatitis: Is There a Shared Inflammatory Network ?

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05994677
Collaborator
(none)
59
12

Study Details

Study Description

Brief Summary

The study is to assess frequency of NASH in Psoriatic patient and to measure the level of proinflammatory cytokines including TNFα, interleukin (IL)-6 and IL-17 and anti-inflammatory cytokines including IL10, IL35 by ELISA.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    • Psoriasis is a chronic proliferative and inflammatory condition of the skin. It is characterized by erythematous plaques covered with silvery scales, particularly over the extensor surfaces, scalp, and lumbosacral region.

    The disorder can also affect the joints and eyes. Psoriasis has no cure and the disease waxes and wanes with flareups. There are several subtypes of psoriasis but the plaque type is the most common and presents on the trunk, extremities, and scalp.

    Psoriasis has a prevalence ranging from 0.2% to 4.8%.

    In parallel, nonalcoholic fatty liver disease (NAFLD) is the most frequent liver disease worldwide, affecting an estimated 30% of the adult population in developed countries.

    NAFLD and the metabolic syndrome are mutually and bi-directionally associated, as these two pathologic condition share insulin resistance as a common pathophysiological mechanism.

    NAFLD encompasses a spectrum of pathologic conditions ranging from simple steatosis to nonalcoholic steatohepatitis((NASH) featuring steatosis associated with inflammatory changes, hepatocellular ballooning and pericellular fibrosis), to advanced fibrosis and cirrhosis. NAFLD is projected to become the most common indication for liver transplantation in the United States by 2030 .

    Over the last few years, multiple studies have demonstrated that psoriasis is associated with NAFLD. The majority reported a prevalence of around 50 % (range 14.4 % to 65.5 %) for NAFLD in psoriatic patients.

    The contribution of IL-17 to the pathogenesis of both psoriasis and NAFLD is intriguing. Th17 cells can be detected in fat tissue and IL-17 itself regulates glucose metabolism and adipogenesis. Likewise, IL-17(A)-secreting Th17 cells may promote the progression from simple steatosis to steatohepatitis [10] Therefore, both psoriasis and NAFLD pathogenesis seem to be linked to the joint proinflammatory Th17 axis (and other cytokines such as TNFα and IL-6).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    59 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Psoriasis and Non Alcoholic Steatohepatitis: Is There a Shared Inflammatory Network ?
    Anticipated Study Start Date :
    Aug 1, 2023
    Anticipated Primary Completion Date :
    Aug 1, 2024
    Anticipated Study Completion Date :
    Aug 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Main [Baseline]

      To find out if there is a shared inflammatory network between psoriasis and Non Alcoholic Steatohepatitis or not.

    Secondary Outcome Measures

    1. subsidiary [Baseline]

      Incidence of Non Alcoholic Steatohepatitis in psoriatic patients.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Any naive psoriatic patient above 18 years old.
    Exclusion Criteria:
    • Any psoriatic patient who received treatment for psoriasis.

    • Diabetic patients.

    • Patients under 18 years old.

    • Patient's refusal.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohamed Adel Mohamed Hussein, Resident doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05994677
    Other Study ID Numbers:
    • AssiutUFMGIT
    First Posted:
    Aug 16, 2023
    Last Update Posted:
    Aug 16, 2023
    Last Verified:
    Aug 1, 2023
    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
    Keywords provided by Mohamed Adel Mohamed Hussein, Resident doctor, Assiut University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 16, 2023