Regulatory BCells in Systemic Lupus Erythematosus

NCT ID: NCT03178721

Last Updated: 2017-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-25

Study Completion Date

2018-07-25

Brief Summary

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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

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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 .

Conditions

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Systemic Lupus Erythematosus

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

OTHER

Study Groups

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1

Systemic lupus erythematosus with atherosclerosis

blood sample

Intervention Type DIAGNOSTIC_TEST

study B regulatory in blood and its correlation with atherosclerosis

2

Systemic lupus erythematosus without atherosclerosis

blood sample

Intervention Type DIAGNOSTIC_TEST

study B regulatory in blood and its correlation with atherosclerosis

Interventions

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blood sample

study B regulatory in blood and its correlation with atherosclerosis

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Coronary calcium scoring: all participants will be scanned using a 64-slice CT scanner and Carotid intimae media thickness (CIMT): Carotid artery ultrasonography

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with clinical atherosclerotic vascular disease
* pregnancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Eman Mohamed Shawky

principle investegator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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breg

Identifier Type: -

Identifier Source: org_study_id

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