Assessment of Endocan Serum Levels in Patients With Behcet Disease

Assessment of Endocan Serum Levels in Patients With Behcet Disease: Relation to Clinical Parameters and Disease Status

The aim of our study was to assess serum endocan levels in patients with Behcet disease and to correlate it with various disease clinical and laboratory parameters of disease activity as well as carotid intima media thickness.

Study Overview

• Status: Completed
• Conditions: Behçet
• Intervention / Treatment: Diagnostic test: measurement of serum endocan

Detailed Description

This study will be carried out on two groups:

• Group (I): Forty two patients diagnosed to have Behcets disease fulfilling the International Criteria for BD .

Group (II): including 42 age and sex matching healthy volunteers as control group.

(A) Clinical evaluation

1. Complete history taking.
2. Thorough clinical examination including opthalmologic evaluation .
3. Disease activity using The Behcet's disease current activity form (BD-DAF) . (B) Laboratory assessment:

All patients will be subjected to the following measurements:

1. ESR
2. CRP
3. CBC
4. liver and kidney function tests

d) Serum Endocan level e)triglycrides f) cholestrol C) carotid intima media thickness

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• Egypt
  • Qalubiya
    • Banhā, Qalubiya, Egypt, 13518
      • Benha University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This study will be carried out on two groups:

• Group (I): Forty two patients diagnosed to have Behcets disease fulfilling the International Criteria for BD .

Group (II): including 42 age and sex matching healthy volunteers as control group.

Description

Inclusion Criteria:

• patients with Behcets disease fulfilling the International Criteria for BD .

Exclusion Criteria:

• infection
• malignancy
• other connective tissue disease
• chronic liver disease
• chronic kidney disease
• Diabetes mellitus
• hypertension
• hyperlipidemia

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Behçet group; Forty two patients diagnosed to have Behçet disease fulfilling the International Study Group Criteria for Behçet disease in whom measurement of serum endocan levels will be performed.	Diagnostic test: measurement of serum endocan; measurement of serum levels of endocan; Other Names: endothelial cell-specific molecule 1
control group; including 42 age and sex matching healthy volunteers as control group in whom measurement of serum endocan levels will be performed.	Diagnostic test: measurement of serum endocan; measurement of serum levels of endocan; Other Names: endothelial cell-specific molecule 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Behcet's disease current activity form (BDCAF)	One point is given to the presence of different organ involvement over the 4 weeks prior to assessment as follows: headache, mouth ulcers, genital ulcers, skin lesions , joint involvement , gastrointestinal symptoms , eye involvement , nervous system involvement , and major vessel involvement.The total score will be out of 12 and higher score indicates worse outcome. we will assess the relation between serum endocan level and BDCAF	: through study completion, an average of 6 months
Erythrocyte sedimentation rate (ESR)	ESR measured in mm/1st hour by westergren method. we will assess the relation between serum endocan level and ESR	: through study completion, an average of 6 months
C reactive protein (CRP)	CRP measured in mg/L using nephlometry. we will assess the relation between serum endocan level and CRP	: through study completion, an average of 6 months
carotid intima media thickness	Color Doppler ultrasonography was performed for both common carotid arteries in a longitudinal orientation and measured with millimeter	: through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 27, 2019
• Primary Completion (ACTUAL): December 16, 2019
• Study Completion (ACTUAL): December 16, 2019

Study Registration Dates

• First Submitted: February 22, 2019
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (ACTUAL): February 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Behçet disease; endocan
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Eye Diseases; Genetic Diseases, Inborn; Stomatognathic Diseases; Mouth Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Vasculitis; Hereditary Autoinflammatory Diseases; Skin Diseases, Genetic; Skin Diseases, Vascular; Behcet Syndrome
• Other Study ID Numbers: BenhaU22019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No