Assessment of Endocan Serum Levels in Patients With Behcet Disease

Behçet Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03853135
• Other study ID #: BenhaU22019
• Status: Completed
• Start date: February 27, 2019
• Est. completion date: December 16, 2019

Study information

• Verified date: January 2020
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 16, 2019
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behçet
• Behcet Syndrome

Intervention

Diagnostic Test:
• measurement of serum endocan
measurement of serum levels of endocan

Locations

Country	Name	City	State
Egypt	Benha University Hospital	Banha	Qalubiya

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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