- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07803198
Asprosin in Behect Patients
Asprosin as a Potential Biomarker for Disease Activity in Behcet Disease
Study Overview
Status
Conditions
Detailed Description
Behçet's disease (BD) is a chronic, recurrent, multisystem inflammatory vasculitis characterized by various systemic manifestations involving all vessel sizes in both the arterial and venous systems [1,2].
Given that BD is a prototypical systemic vasculitis in which endothelial damage and vascular inflammation are central pathogenic mechanisms, the identification of novel biomarkers reflecting vascular involvement is of major clinical importance[3].
Asprosin is an adipokine that beyond its metabolic effects, carries growing evidence suggesting its associated with vascular pathologies [4].
Experimental and clinical studies have demonstrated that Asprosin contributes to endothelial dysfunction, induces phenotypic switching in vascular smooth muscle cells, and facilitates vascular remodeling by activating pro-inflammatory signaling pathways such as TLR4-NF-κB-NLRP3 [4,5]. Furthermore, Asprosin has been implicated in endothelial-to-mesenchymal transition through TGF-β signaling, thereby exacerbating peripheral arterial disease and vascular stiffness[4,5]. Although endothelial dysfunction and surrogate markers of vascular injury (e.g., impaired flow-mediated dilation, increased intima-media thickness, oxidative stress markers) have been extensively studied in BD[3], the role of Asprosin in this disease remains unexplored.
In this context, Asprosin may represent a link between metabolic pathways and immune mediated vascular inflammation, warranting investigation in systemic vasculitis as potential biomarkers of disease activity [6].
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Eman Ahmed Ibrahim
- Phone Number: 01155359235
- Email: eymanahmad159@gmail.com
Study Contact Backup
- Name: Samar Hasanein Goma, MD
- Phone Number: 01061828586
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult subjects (≥ 18 years) satisfying the International Criteria for Behçet's Disease (ICBD) will be included in [7].
Exclusion Criteria:
- Patients with other autoimmune diseases.
- Patients with Acute inflammatory condition at the time of blood sampling.
- Pregnant participants, and participants with active infection, known malignancy, diabetes mellitus, chronic kidney or liver disease, thyroid or other endocrine disorders, obesity.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of asprosin level in behcet disease and its association with disease activity
Time Frame: Baseline
|
To investigate serum asprosin level in behcet disease
|
Baseline
|
|
Assessment of asprosin level in behcet disease and its association with disease activity
Time Frame: Baseline assessment at the time of enrollment
|
To investigate serum Asprosin concentrations in patients with BD.
|
Baseline assessment at the time of enrollment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Marwa Ahmed Abdel- aziz Galal, MD, Assiut University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
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
Additional Relevant MeSH Terms
- Mouth Diseases
- Stomatognathic Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Genetic Diseases, Inborn
- Eye Diseases
- Skin Diseases
- Skin Diseases, Vascular
- Skin Diseases, Genetic
- Uveal Diseases
- Vasculitis
- Panuveitis
- Uveitis, Anterior
- Uveitis
- Hereditary Autoinflammatory Diseases
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Skin and Connective Tissue Diseases
- Behcet Syndrome
Other Study ID Numbers
- Asprosin in behcet patients
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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