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Assessment of Endocan Serum Levels in Patients With Behcet Disease

Sponsor
Benha University (Other)
Overall Status
Completed
CT.gov ID
NCT03853135
Collaborator
(none)
84
Enrollment
1
Location
9.6
Actual Duration (Months)
8.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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

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

Study Design

Study Type:
Observational
Actual Enrollment :
84 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Assessment of Endocan Serum Levels in Patients With Behcet Disease: Relation to Clinical Parameters and Disease Status
Actual Study Start Date :
Feb 27, 2019
Actual Primary Completion Date :
Dec 16, 2019
Actual Study Completion Date :
Dec 16, 2019

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. 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

    4. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Benha University Hospital Banhā Qalubiya Egypt 13518

    Sponsors and Collaborators

    • Benha University

    Investigators

    • Principal Investigator: Waleed Hassan, MD, Benha university- Qaluibya- Egypt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Waleed Ahmed Salaheldeen Hassan, Assistant professor, Benha University
    ClinicalTrials.gov Identifier:
    NCT03853135
    Other Study ID Numbers:
    • BenhaU22019
    First Posted:
    Feb 25, 2019
    Last Update Posted:
    Jan 6, 2020
    Last Verified:
    Jan 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Waleed Ahmed Salaheldeen Hassan, Assistant professor, Benha University
    Behçet disease
    endocan
    Additional relevant MeSH terms:
    Behcet Syndrome

    Study Results

    No Results Posted as of Jan 6, 2020