Serum Ceramides Level in Systemic Lupus Erythematosus (SLE) Patients as a Novel Marker for Renal Impairment

• Conditions: Systemic Lupus
• Interventions: Diagnostic Test: serum ceramides level in blood

• Registration Number: NCT04256577
• Lead Sponsor: Assiut University

Brief Summary

1. Estimation of serum ceramides level in SLE patients as anovel marker for renal impairment

2. Correlation serum ceramides level with histological classification of LN,C3,C4,ANA,ANTI DS DNA ,CRP ,ESR , eGFR , creatinine /protein ratio

3. Follow up estimation of ceramides level in LN patients after 3 cycles of treatment

Detailed Description

Systemic lupus erythrematosus (SLE) is an autoimmune disease with increasing prevalence and incidence , The clinical manifestation is multifaceted and targets the musculoskeletal system, the skin and different organs like lung and kidney From 30-80% of SLE patients develop lupus nephritis (LN) which often leads to chronic kidney disease (CKD) and end-stage renal disease (ESRD) and is associated with an overall poor prognosis and high mortality Diagnosis of LN is made by kidney biopsy, which still remains the gold standard Histological evaluation distinguish between different stages of LN upon morphological changes within the kidney . However, noninvasive methods to diagnose and guide LN therapy are currently not established in the clinic. On the other hand, an early diagnosis is important for the therapeutic success and thereby lowers the risk of ESRD In this context, classical clinical markers for renal dysfunction are insufficient for an early assessment of the need for renal biopsies and subsequently to decide about the optimal therapy. Even though traditional biomarkers like antids DNA antibodies and complement deficiency are widely accepted as diagnostic instruments to assess disease activity, their specificity is rather low, and they appear to be more suitable to confirm diagnosis of SLE and LN in an already likely clinical setting Ceramides are a family of waxy lipid molecules ,composed of sphingosine and fatty acide ,found in high concentration with in the cell membrane of eukaryocyte cells, since they are component lipids that make up sphingomyelin, one of the major lipids in the lipid bilayer Ceramides and other sphingolipids found in cell membrane were purely supporting structural elements,also participate in variety of cellular signaling, regulating differentiation, proliferation, Programmed cell death(PCD) Sphingolipids are a heterogenous group of lipids with more than 400 single compounds formed by structural and chemical modifications of a sphingosine backbone Recent studies reveal that blood sphingolipids not only have important signaling properties but also serve as biomarkers in various renal disease Patyna etal in 2019 concluded that ceramides in blood could act as potent biomarker for renal impairment in patient

Study Timeline

• Status Verified: 2020-01
• Study Start: 2020-02
• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-03
• Study First Posted: 2020-02-05
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-17
• Primary Completion: 2021-02
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Forty five patients will SLE with and without renal impairment diagnosed as SLE according to SLICC classification criteria for SLE

Exclusion Criteria

• Malignant tumor ,infectious diseases, Alzheimer disease ,type 2 diabetes mellitus vitamin D intaker, obesty , cardiovascular disease (HTN,HF ,ischemic heart disease)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients proven having (SLE)	serum ceramides level in blood	20 patients proven to have systemic lupus Erthematosus without renal impairment (eGFR) ≥ 80 ml/min/1.73 m2 and albumin / creatinine ≤ 30 mg/g)
patients proven to have (LN) by renal biopsy	serum ceramides level in blood	Group (2) 25 patients proven to have LN by renal biopsy before starting treatment and after 3 cycle of treatment (eGFR \< 80 ml/min/1.73 m2 and albumin/creatinine ratio \> 30 mg/g)
healthy control	serum ceramides level in blood	(20) patients healthy control matched in age and sex

Primary Outcome Measures

Name	Time	Method
Estimation of serum ceramides level in SLE patients as anovel marker for renal impairment	base line	Correlation serum ceramides level with histological classification of LN,C3,C4,ANA,ANTI DS DNA ,CRP ,ESR , eGFR , creatinine /protein ratio