Serum Levels of Angiotensin Converting Enzyme in Systemic Lupus Erythematous Patients

NCT05516511 | Unknown

• 1 other identifier: Soh-Med-22-08-01
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease that involve many different organs and display a variable clinical course.The prevalence of SLE varies across gender, race/ethnicity, and geographic regions. SLE demonstrates a striking female predominance with a peak incidence of disease during the reproductive years. In adults, the female to male ratio is 10- Renal involvement is common in SLE and is a significant cause of morbidity and mortality. It is estimated that as many as 90% of patients with SLE will have pathologic evidence of renal involvement on biopsy, but clinically significant nephritis will develop in only 50%. AII is a potent pro-inflammatory modulator with the ability to augment the immune responses in renal and non-renal tissues. Specifically in the kidney, AII stimulates mononuclear cells, favoring hyperplasia and hypertrophy of mesangial, tubular cells and interstitial fibroblasts, and increases expression and synthesis of the extracellular protein matrix leading to fibrosis. Angiotensin II and strong candidate for a mediator of the development and progression of renal disease in SLE has been found to promote glomerular cell proliferation, alter growth factor expression, and activate proinflammatory cytokines, all of which promote glomerulosclerosis

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (3)

• Angiotensin Converting Enzyme test

  laboratory test, ELISA kits, measure serum levels of angiotensin converting enzyme in SLE patients , control

  3 months

• protein creatine ratio

  laboratory test, urine sample used to measure amount of proteinurea

  3 months

• serum creatine test

  lab test , to asses renal function

  3 months

Secondary Outcomes (2)

• Anti nuclear Anti body tset

  3 months

• anti ds-DNA test

  3 months

Study Arms (2)

cases

systemic lupus erythematosus patients

Diagnostic Test: Angiotensin Converting Enzyme test

control

healthy individuals

Diagnostic Test: Angiotensin Converting Enzyme test

Interventions

Angiotensin Converting Enzyme test DIAGNOSTIC_TEST

blood sample is taken SLE patients , healthy control , ACE level will be measured by ELISA kits

cases; control

Eligibility Criteria

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

Study Population

The study will include 50 patients diagnosed by 2019 American College of Rheumatology/European League Against Rheumatism classification criteria as systemic lupus erythematosus, 25of them will be selected as Lupus Nephritis (LN). \- 25 normal healthy persons matched for age and sex as control group.

You may qualify if:

• Patients who fulfill the 2019 American College of Rheumatology/European League against Rheumatism classification criteria of Systemic Lupus Erythematosus 2-Patients diagnosed as lupus nephritis , actually did renal biobsy 3-Patients who is able to give informed consent to join the study

You may not qualify if:

• \- Any patient with any collagen disease other than systemic lupus erythematosus.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

• Pons-Estel GJ, Alarcon GS, Scofield L, Reinlib L, Cooper GS. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthritis Rheum. 2010 Feb;39(4):257-68. doi: 10.1016/j.semarthrit.2008.10.007. Epub 2009 Jan 10.

  PMID: 19136143 BACKGROUND

• Weening JJ, D'Agati VD, Schwartz MM, Seshan SV, Alpers CE, Appel GB, Balow JE, Bruijn JA, Cook T, Ferrario F, Fogo AB, Ginzler EM, Hebert L, Hill G, Hill P, Jennette JC, Kong NC, Lesavre P, Lockshin M, Looi LM, Makino H, Moura LA, Nagata M; International Society of Nephrology Working Group on the Classification of Lupus Nephritis; Renal Pathology Society Working Group on the Classification of Lupus Nephritis. The classification of glomerulonephritis in systemic lupus erythematosus revisited. Kidney Int. 2004 Feb;65(2):521-30. doi: 10.1111/j.1523-1755.2004.00443.x.

  PMID: 14717922 BACKGROUND

• Ruiz-Ortega M, Ruperez M, Esteban V, Rodriguez-Vita J, Sanchez-Lopez E, Carvajal G, Egido J. Angiotensin II: a key factor in the inflammatory and fibrotic response in kidney diseases. Nephrol Dial Transplant. 2006 Jan;21(1):16-20. doi: 10.1093/ndt/gfi265. Epub 2005 Nov 9.

  PMID: 16280370 BACKGROUND

• Klahr S, Morrissey JJ. The role of vasoactive compounds, growth factors and cytokines in the progression of renal disease. Kidney Int Suppl. 2000 Apr;75:S7-14.

  PMID: 10828755 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Yasmine A Mohamed, resident

CONTACT

01032071095; yasmine_abdelfattah_post@med.sohag.edu.eg

Mohamed A Ismail, assisstant professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Physical medicine,Rheumatolgy and Rehabilitaion Department , Faculty of medicine, Sohag University

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 25, 2022
• Study Start: January 1, 2023
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)