ClinicalTrials.gov record NCT07803198
Asprosin in Behect Patients
Asprosin as a Potential Biomarker for Disease Activity in Behcet Disease
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This observational case-control study will measure blood Asprosin levels in adults with Behcet Disease and in age- and sex-matched healthy controls. It will compare Asprosin levels with clinical measures of disease activity and main disease features. Measurements are taken at baseline (one-time assessment) when participants enroll.
What it is studying. The study is testing whether serum Asprosin concentrations are related to disease activity and major clinical manifestations in Behcet Disease.
What the researchers hope to learn. To investigate serum Asprosin levels in Behcet Disease and their relationship with disease activity and major clinical manifestations. The study aims to explore whether Asprosin could serve as a biomarker reflecting vascular involvement or links between metabolic pathways and immune-mediated vascular inflammation in Behcet Disease.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
This study aims to investigate serum Asprosin concentrations in patients with BD and their relationship with disease activity and major clinical manifestations.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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 description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
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].
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
The study is cross-sectional and involves a single baseline visit. At that visit researchers will collect a blood sample to measure serum Asprosin and will assess disease activity in participants with Behcet Disease; healthy volunteers will give a blood sample and basic matching information. The registry does not describe any treatments, repeated visits, or other procedures beyond the baseline assessment.
How the study is structured. This is an observational case-control, cross-sectional study. Adults who meet criteria for Behcet Disease and matched healthy controls give a blood sample at enrollment for serum Asprosin measurement while clinical features and disease activity are recorded. There is no assigned treatment or long-term follow-up described.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Behcet Disease. Does it apply to my diagnosis?
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- No sites are listed on the registry yet. Where will the study take place?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on familial Mediterranean fever
This trial is also listed on this site under Behçet's disease and Marfan syndrome.
Important dates
- Study start
- Sep 1, 2026 (estimated)
- Primary completion
- Sep 30, 2027 (estimated)
- Study completion
- Oct 30, 2027 (estimated)
- Target enrollment
- 44 participants (estimated)
- Last updated on registry
- Sep 3, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Assiut University
- Principal investigator
- Eman Ahmed Ibrahim Hasan, Doctor
Assiut University
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Eman Ahmed Ibrahim 📞 01155359235 ✉ eymanahmad159@gmail.com
- Samar Hasanein Goma, MD 📞 01061828586
Participating sites
Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.
Terms used on this page · explanations by MedicalUpdates.ai
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- biomarkers
- Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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