Serum Levels of Angiotensin Converting Enzyme in Systemic Lupus Erythematous Patients

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

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Diagnostic test: Angiotensin Converting Enzyme test

• Study Type: Observational
• Enrollment (Anticipated): 75

Contacts and Locations

• Study Contact: Name: Yasmine A Mohamed, resident; Phone Number: 01032071095; Email: yasmine_abdelfattah_post@med.sohag.edu.eg
• Study Contact Backup: Name: Mohamed A Ismail, assisstant professor

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 60 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cases; systemic lupus erythematosus patients	Diagnostic test: Angiotensin Converting Enzyme test; blood sample is taken SLE patients , healthy control , ACE level will be measured by ELISA kits
control; healthy individuals	Diagnostic test: Angiotensin Converting Enzyme test; blood sample is taken SLE patients , healthy control , ACE level will be measured by ELISA kits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti nuclear Anti body tset	lab tset, IF technique, for diagnosis of SLE disease	3 months
anti ds-DNA test	lab test , for diagnosis of SLE , lupus nephritis	3 months

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Kidney Int. 2004 Mar;65(3):1132.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2023
• Primary Completion (ANTICIPATED): March 1, 2023
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (ACTUAL): August 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: Soh-Med-22-08-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

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