Clinical trial NCT05516511: Serum Levels of Angiotensin Converting Enzyme in Systemic Lupus Erythematous Patients
Official title: Serum Levels of Angiotensin Converting Enzyme in Systemic Lupus Erythematous Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 75
Sex: ALL
Minimum age (years): 17
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Angiotensin Converting Enzyme test
timeFrame: 3 months
measure: protein creatine ratio
timeFrame: 3 months
measure: serum creatine test
timeFrame: 3 months
Secondary outcomes:
measure: Anti nuclear Anti body tset
timeFrame: 3 months
measure: anti ds-DNA test
timeFrame: 3 months
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: 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.
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. doi: 10.1111/j.1523-1755.2004.00443.x.
citation: 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.
citation: 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.