Regulatory BCells in Systemic Lupus Erythematosus

• Conditions: Systemic Lupus Erythematosus
• Interventions: Diagnostic Test: blood sample

• Registration Number: NCT03178721
• Lead Sponsor: Assiut University

Brief Summary

Systemic lupus erythematosus , the archetypal multisystem autoimmune disease, presents many diagnostic and management challenges. One such challenge is the excess cardiovascular disease observed in patients with Systemic lupus erythematosus . Coronary heart disease and other manifestations of atherosclerosis continue to be a major cause of death in patients with Systemic lupus erythematosus.Regulatory B-cells have been identified as a negative regulator of the immune system that inhibit pathological immune response by suppressing both uncontrolled protective immune response and damaging autoimmune responses

Detailed Description

Regulatory B cells have been identified as an IL10 producing B cells subsets that are characterized by the expression of CD19 CD24hiCD38hi . Breg cells can inhibit inflammatory responses in autoimmune disease, like Systemic lupus erythematosus, via the production of IL-10 (an antiatherogenic cytokine) which will suppress TNF- α production by monocytes leading to inhibition of T cell-mediated inflammation. Regulatory B have a vital role in immune tolerance and their deficiency resulted in exacerbation of autoimmunity . Evidence suggests Breg in autoimmune disease may be dysfunctional .

In this proposal, We suggest IL-10 production by Breg confers an atheroprotective role. In Systemic lupus erythematosus, Regulatory B ability to control atherosclerosis is reduced therefore, we will test the hypothesis that Regulatory B play an important role in both autoimmunity and accelerated atherosclerosis and dysfunction in Regulatory B from autoimmune disease may or may not result in a reduced ability to control atherosclerosis .

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-30
• Study First Submitted QC: 2017-06-05
• Last Update Submitted: 2017-06-05
• Study First Posted: 2017-06-07
• Last Update Posted: 2017-06-07
• Study Start: 2017-06-25
• Primary Completion: 2018-06-25
• Study Completion: 2018-07-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Clinical and laboratory Diagnosis of Systemic Lupus disease.
• Must be adult.

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Exclusion Criteria

• Patients with clinical atherosclerotic vascular disease
• pregnancy.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	blood sample	Systemic lupus erythematosus with atherosclerosis
2	blood sample	Systemic lupus erythematosus without atherosclerosis

Primary Outcome Measures

Name	Time	Method
Coronary calcium scoring	1year	using Agatston score none (Agatston 0 U) mild (Agatston 1-99 U) moderate(Agatston 100-399 U) high(Agatston \>400 U)