- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07320872
Correlation Between Vaspin Gene Polymorphism and Serum Vaspin Levels in Psoriasis Vulgaris
Correlation Between Vaspin Gene Polymorphism and Serum Vaspin Levels in Psoriasis Vulgaris and Its Relation to Pathogenesis and Risk of the Disease
Psoriasis is a common immune-mediated inflammatory skin disease affecting at least 100 million individuals worldwide. In Egypt, the prevalence of psoriasis ranges between 0.19% and 3% of the Egyptian people.
It is associated with poor quality of life, reduced life expectancy and multimorbidity including psoriatic arthritis, obesity and cardiovascular disease.
Vaspin (VASP, SERPIN 12) is a recently discovered adipokine that has been isolated from the visceral adipose tissue of a rat model of type 2 diabetes. It is coded by the gene SERPNA12 located on the long arm of chromosome 14q32.13 and consists of six exons and five introns.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Psoriasis can present at any age. However, the disease onset appears to follow a bimodal distribution, peaking around 20-30 years of age and again around 50-60 years of age.
Psoriasis is a common skin disease characterized clinically by formation of erythematous and scaly plaques at different sites affecting mainly the extensor prominences, scalp, the lumbosacral area and the sites of trauma. It is a lifelong disease with spontaneous remissions and exacerbations.
The exact etiology is unknown, but it is considered to be an autoimmune disease mediated by T lymphocytes. It is considered the most prevalent T-cell-mediated inflammatory disease in human beings, in which, keratinocytes in focal skin regions are stimulated to proliferate with activation of the immune system mediated by primed T-lymphocytes.
There is an association of HLA antigens seen in many psoriatic patients, particularly in various racial and ethnic groups. Familial occurrence suggests its genetic predisposition .
The pathophysiology of psoriasis involves infiltration of the skin by activated T cells which stimulate the proliferation of keratinocytes. This dysregulation in keratinocyte turnover results in the formation of thick plaques. Other associated features include epidermal hyperplasia and parakeratosis. There are several treatment options available for mild psoriasis, including topical corticosteroids, vitamin D analogs, calcineurin inhibitors, keratolytics, and targeted phototherapy.
More severe disease might require systemic therapy, including phototherapy, acitretin, methotrexate, cyclosporine, or biologic therapy. Psoriasis is accompanied by comorbidities such as obesity, diabetes, and metaboloic syndrome. Although the pathogenesis is still unknown, systemic inflammation caused by adipokines released from visceral adipose tissue is thought to play a role .
Adipokines are various bioactive polypeptides produced and released by adipose tissue. Adipokines are thought to play an important role in the pathogenesis of obesity-related diseases such as insulin resistance, hypertension, inflammation, and metabolic disorders.
Vaspin (visceral adipose tissue-derived serine protease inhibitor also called Serpin A12), It belongs to the serpin group of proteins and is a serine protease inhibitor produced from visceral adipose tissue.Vaspin consists of 415 amino acids and weighing 47-kDa .
Vaspin is an adipokine with recently described anti-inflammatory properties. It has been reported to be expressed in various tissues, such as skin, liver, stomach and pancreas, in addition to adipose tissue in humans . The main source of vaspin in human skin was found to be keratinocytes. Vaspin in the skin is associated with the differentiation of keratinocytes and suppresses the expression of inflammatory mediators.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mahmoud Ahmed Ali, Lecturer
- Phone Number: +201002364902
- Email: dr.mahmoudali@aswu.edu.eg
Study Contact Backup
- Name: Ola Mahmoud Samy Mohamed, MSC
- Phone Number: +201025592922
- Email: olaelqousy@gmail.com
Study Locations
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Aswān, Egypt
- Recruiting
- Aswan university hospital
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Contact:
- Mostafa Adam Ali El Taieb, Professor
- Phone Number: +201092991101
- Email: moustafa.eltaib@aswu.edu.eg
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Contact:
- Mohamed Amer Ahmed Abdellatif, Lecturer
- Phone Number: +201060394083
- Email: mohammed.abdellatif@aswu.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Newly diagnosed cases or stopped treatment of at least 6 months of psoriasis patients.
- Pateints with any age and gender.
Exclusion Criteria:
- Pregnancy and lactation.
- Patients with chronic diseases: cardiac diseases, hepatic disorders, chronic renal failure or malignancies.
- Patients with associated inflammatory disease such as infections and autoimmune diseases.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Group A: Psoriasis Patients
About 30 patients suffering from Psoriasis Vulgaris will subject to vaspin gene polymorphism measure and Assessment of the disease severity will be performed by using Psoriasis area and severity index score (PASI score) for all patients.
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to detect the correlation between vaspin gene polymorphism and serum vaspin levels among psoriasis patients.
Other Names:
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Group B: Control Group
About 30 healthy participants will share as A control Group
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to detect the correlation between vaspin gene polymorphism and serum vaspin levels among psoriasis patients.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Detection of vaspin gene polymorphism
Time Frame: 12 Months
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Assessment of vaspin gene polymorphism in psoriasis patients to determine the disease severity
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12 Months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Moustafa Adam Ali El Taieb, Professor, Dermatology, Venereology and Andrology.Faculty of Medicine, Aswan University
- Study Director: Hoda Soltan Sherkawy El Bakry, Lecturer, Medical biochemistry,Faculty of Medicine,Aswan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Psoriasis Vulgaris Vaspin Gene
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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