Serum Levels of Angiotensin Converting Enzyme in Systemic Lupus Erythematous Patients

Systemic Lupus Erythematosus Clinical Trial

Official title:

Serum Levels of Angiotensin Converting Enzyme in Systemic Lupus Erythematous Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05516511
• Other study ID #: Soh-Med-22-08-01
• Status: Not yet recruiting
• Start date: January 2023
• Est. completion date: March 2023

Study information

• Verified date: November 2022
• Source: Sohag University
• Contact: Yasmine A Mohamed, resident
• Phone: 01032071095
• Email: yasmine_abdelfattah_post[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 60 Years

Eligibility

Inclusion Criteria:

• 1-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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Diagnostic Test:
• Angiotensin Converting Enzyme test
blood sample is taken SLE patients , healthy control , ACE level will be measured by ELISA kits

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. Review. — View Citation

Pons-Estel GJ, Alarcón 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. Review. — View Citation

Ruiz-Ortega M, Rupérez M, Esteban V, Rodríguez-Vita J, Sánchez-López 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. Epub 2005 Nov 9. Review. — View Citation

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. Review. Erratum in: Kidney Int. 2004 Mar;65(3):1132. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiotensin Converting Enzyme test	laboratory test, ELISA kits, measure serum levels of angiotensin converting enzyme in SLE patients , control	3 months
Primary	protein creatine ratio	laboratory test, urine sample used to measure amount of proteinurea	3 months
Primary	serum creatine test	lab test , to asses renal function	3 months
Secondary	Anti nuclear Anti body tset	lab tset, IF technique, for diagnosis of SLE disease	3 months
Secondary	anti ds-DNA test	lab test , for diagnosis of SLE , lupus nephritis	3 months