Regulatory BCells in Systemic Lupus Erythematosus

Regulatory BCells in Systemic Lupus Erythematosus and Its Relation to Atherosclerosis and Disease Activity

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

Study Overview

• Status: Unknown
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Diagnostic test: blood sample

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 .

• Study Type: Observational
• Enrollment (Anticipated): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

adult patients with systemic lupus erythematosus

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with clinical atherosclerotic vascular disease
• pregnancy.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Systemic lupus erythematosus with atherosclerosis	Diagnostic test: blood sample; study B regulatory in blood and its correlation with atherosclerosis; Other Names: Coronary calcium scoring: all participants will be scanned using a 64-slice CT scanner and Carotid intimae media thickness (CIMT): Carotid artery ultrasonography
2; Systemic lupus erythematosus without atherosclerosis	Diagnostic test: blood sample; study B regulatory in blood and its correlation with atherosclerosis; Other Names: Coronary calcium scoring: all participants will be scanned using a 64-slice CT scanner and Carotid intimae media thickness (CIMT): Carotid artery ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coronary calcium scoring	using Agatston score none (Agatston 0 U) mild (Agatston 1-99 U) moderate(Agatston 100-399 U) high(Agatston >400 U)	1year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 25, 2017
• Primary Completion (ANTICIPATED): June 25, 2018
• Study Completion (ANTICIPATED): July 25, 2018

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: June 5, 2017
• First Posted (ACTUAL): June 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2017
• Last Update Submitted That Met QC Criteria: June 5, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: breg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No