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

• ClinicalTrials.gov Identifier: NCT05994677
• Recruitment Status: Not yet recruiting
• First Posted: August 16, 2023
• Last Update Posted: August 16, 2023
• Sponsor: Assiut University
• Information provided by (Responsible Party): Mohamed Adel Mohamed Hussein, Assiut University

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
Nash

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

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Main [ Time Frame: Baseline ]
   To find out if there is a shared inflammatory network between psoriasis and Non Alcoholic Steatohepatitis or not.

Secondary Outcome Measures :

1. subsidiary [ Time Frame: Baseline ]
   Incidence of Non Alcoholic Steatohepatitis in psoriatic patients.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

Study Population

Psoriatic patients above 18 years not diabetic and not receiving treatment for psoriasis.

Criteria

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

No Contacts or Locations Provided

More Information

• Responsible Party: Mohamed Adel Mohamed Hussein, Resident doctor, Assiut University
• ClinicalTrials.gov Identifier: NCT05994677
• Other Study ID Numbers: AssiutUFMGIT
• First Posted: August 16, 2023
• Last Update Posted: August 16, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• 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, Assiut University:

NASH; Psoriasis

Additional relevant MeSH terms:

Fatty Liver; Non-alcoholic Fatty Liver Disease; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Liver Diseases; Digestive System Diseases