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

NCT04256577 | Unknown

• 1 other identifier: serum ceramides level in (SLE)
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Estimation of serum ceramides level in SLE patients as anovel marker for renal impairment
2. 2.Correlation serum ceramides level with histological classification of LN,C3,C4,ANA,ANTI DS DNA ,CRP ,ESR , eGFR , creatinine /protein ratio
3. 3.Follow up estimation of ceramides level in LN patients after 3 cycles of treatment

Conditions

Systemic Lupus

Outcome Measures

Primary Outcomes (1)

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

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

  base line

Study Arms (3)

patients proven having (SLE)

20 patients proven to have systemic lupus Erthematosus without renal impairment (eGFR) ≥ 80 ml/min/1.73 m2 and albumin / creatinine ≤ 30 mg/g)

Diagnostic Test: serum ceramides level in blood

patients proven to have (LN) by renal biopsy

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)

Diagnostic Test: serum ceramides level in blood

healthy control

(20) patients healthy control matched in age and sex

Diagnostic Test: serum ceramides level in blood

Interventions

serum ceramides level in blood DIAGNOSTIC_TEST

Serum ceramides ( sphingolipid measurement, plasma (EDTA as anticoagulant) and serum separation was performed immediately after blood drawing by two-time scentrifugation at 750 x g for 5 min (4°C). Lipid extraction from plasma and/or serum samples (10 µl each) and subsequent LC-MS/MS)

healthy control; patients proven having (SLE); patients proven to have (LN) by renal biopsy

Eligibility Criteria

• Age: 17 Years - 60 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Prospective analytic (cross\_section) study will be carried out on patients admitted to assiut university hospital internal medicine department.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Patyna S, Buttner S, Eckes T, Obermuller N, Bartel C, Braner A, Trautmann S, Thomas D, Geiger H, Pfeilschifter J, Koch A. Blood ceramides as novel markers for renal impairment in systemic lupus erythematosus. Prostaglandins Other Lipid Mediat. 2019 Oct;144:106348. doi: 10.1016/j.prostaglandins.2019.106348. Epub 2019 Jul 10.

  PMID: 31301404 BACKGROUND

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

nadia hussien hammam, Resident doctor

CONTACT

01006912253; dr.nadia_hussien@yahoo.com

Nabawia Mahmoud Tawfik, Professor

CONTACT

01223971418; Nabawia.tawfik@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 5, 2020
• Study Start: February 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: June 1, 2021
• Last Updated: February 17, 2020

Record last verified: 2020-01