NashPANASHNCT05994677
Psoriasis and Non Alcoholic Steatohepatitis: Is There a Shared Inflammatory Network ?
An observational study of Nash, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nash
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Psoriatic patients above 18 years not diabetic and not receiving treatment for psoriasis.
Who may be able to join
- Any naive psoriatic patient above 18 years old.
Who cannot join
- Any psoriatic patient who received treatment for psoriasis.
- Diabetic patients.
- Patients under 18 years old.
- Patient's refusal.
About this study
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.
Read the 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).
- Conditions
- Nash
- Keywords
- NASH, Psoriasis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Psoriasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Main
To find out if there is a shared inflammatory network between psoriasis and Non Alcoholic Steatohepatitis or not.
Measured: Baseline
Secondary outcomes (1)
subsidiary
Incidence of Non Alcoholic Steatohepatitis in psoriatic patients.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NashStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Adel Mohamed Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994677
- Sponsor's protocol ID
- AssiutUFMGIT
- Acronym
- PANASH
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psoriasis and Non Alcoholic Steatohepatitis: Is There a Shared Inflammatory Network ?
- ClinicalTrials.gov ID
- NCT05994677
- Acronym / sponsor ID
- PANASH / AssiutUFMGIT
- Conditions
- Nash
- Keywords
- NASH, Psoriasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Psoriatic patients above 18 years not diabetic and not receiving treatment for psoriasis.
Key inclusion criteria (1 listed)
- Any naive psoriatic patient above 18 years old.
Key exclusion criteria (4 listed)
- Any psoriatic patient who received treatment for psoriasis.
- Diabetic patients.
- Patients under 18 years old.
- Patient's refusal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Main
Time frame: Baseline
To find out if there is a shared inflammatory network between psoriasis and Non Alcoholic Steatohepatitis or not.
1 secondary outcome
subsidiary
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Nash
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NAFLD Clinical Care Pathway
NAFLD, MASLD
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Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Nash, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.