Assessment of Endocan Serum Levels in Patients With Behcet Disease

Completed

• Conditions: Behçet
• Interventions: Diagnostic Test: measurement of serum endocan

• Registration Number: NCT03853135
• Lead Sponsor: Benha University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-02-22
• Study First Submitted QC: 2019-02-22
• Study First Posted: 2019-02-25
• Study Start: 2019-02-27
• Primary Completion: 2019-12-16
• Study Completion: 2019-12-16
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-02
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	measurement of serum endocan	including 42 age and sex matching healthy volunteers as control group in whom measurement of serum endocan levels will be performed.
Behçet group	measurement of serum endocan	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.

Primary Outcome Measures

Name	Time	Method
the Behcet's disease current activity form (BDCAF)	: through study completion, an average of 6 months	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
Erythrocyte sedimentation rate (ESR)	: through study completion, an average of 6 months	ESR measured in mm/1st hour by westergren method. we will assess the relation between serum endocan level and ESR
C reactive protein (CRP)	: through study completion, an average of 6 months	CRP measured in mg/L using nephlometry. we will assess the relation between serum endocan level and CRP
carotid intima media thickness	: through study completion, an average of 6 months	Color Doppler ultrasonography was performed for both common carotid arteries in a longitudinal orientation and measured with millimeter

Trial Locations

Locations (1)

Benha University Hospital; 🇪🇬 Banhā, Qalubiya, Egypt