the Association Between Metabolic Syndrome and Its Components With Lupus Nephritis in Systemic Lupus Erythematosus Patients

Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease that involve s 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 10-15:1.

Clinical features in individual patients can be quite variable and range from mild joint and skin involvement to severe, life-threatening internal organ disease. Constitutional symptoms, rash, mucosal ulcers, inflammatory polyarthritis, photosensitivity, and serositis are the most common clinical features of the disease .

Major organ affection in SLE includes Neuropsychiatric involvement (cognitive impairment, depression, psychosis, seizures, stroke, demyelinating syndromes, peripheral neuropathy, etc.) and cardiopulmonary manifestations. Lupus nephritis is the most common of the potentially life-threatening manifestations .

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%.

Lupus involvement in the kidney manifests as urinary findings (proteinuria, hematuria, pathologic casts) with or without a rise in serum creatinine. The specific criteria listed for renal involvement are a urine protein > 500 mg/dL or red blood cell casts, Lupus nephritis is often confirmed by kidney biopsy, with the results showing one or more of the classes of lupus nephritis.

The metabolic syndrome is a prevalent disorder which is defined by the presence of central obesity, dyslipidemia, hypertension, and disturbed glucose metabolism . It is known that Metabolic syndrome predisposes to cardiovascular disease (CVD) and consequently, to a rise in CVD morbidity and mortality. This syndrome plays a major role in the complex network of systemic pro-inflammatory and prothrombotic states involved in the development of CVD .

Compared with patients without Metabolic syndrome, SLE patients from the multinational, multiethnic Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) cohort with the diagnosis of Metabolic syndrome were older, had a higher disease activity, an increased number of recent disease flares, and had accrued more organ damage . Mok et al report that Metabolic syndrome is significantly associated with new organ damage, vascular events, and mortality in patients with SLE .

Study Overview

• Status: Not yet recruiting
• Conditions: Lupus Nephritis
• Intervention / Treatment: Diagnostic test: lipid profile; Diagnostic test: fasting blood suger

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: mohamed s ali, resident; Phone Number: 01015159035; Email: mohamedsalah@med.sohag.edu.eg
• Study Contact Backup: Name: sahar a al-rahman, assistant professor

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University Hospital
    • Contact: Magdy M Amin, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Age less than 18 years . Patient not able and willing to give written informed consent. Patients with pregnancy, cancer and with viral infectious diseases. Patients with other autoimmune diseases rather than SLE.

Description

Inclusion Criteria:

• 1. Age less than 18 years . 2. Patient not able and willing to give written informed consent. 3. Patients with pregnancy, cancer and with viral infectious diseases. 4. Patients with other autoimmune diseases rather than SLE.

Exclusion Criteria:

• 1. Age less than 18 years . 2. Patient not able and willing to give written informed consent. 3. Patients with pregnancy, cancer and with viral infectious diseases. 4. Patients with other autoimmune diseases rather than SLE.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patinets with lupus nephritis; patients diagnosed as lupus nehpritis	Diagnostic test: lipid profile; measuerments of lipid profile parameters to detect hyperlipidemia; Diagnostic test: fasting blood suger; measurment of fasting blood suger to detect hyprerglicemia
pathents without lupus nephritis; sle pathients not diagnosed as lupus nephritis	Diagnostic test: lipid profile; measuerments of lipid profile parameters to detect hyperlipidemia; Diagnostic test: fasting blood suger; measurment of fasting blood suger to detect hyprerglicemia
controls; controls will be matched for sex, age, and level of schooling withot history of connective tissue disorders, systemic active disease and renal history	Diagnostic test: lipid profile; measuerments of lipid profile parameters to detect hyperlipidemia; Diagnostic test: fasting blood suger; measurment of fasting blood suger to detect hyprerglicemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lipid profile (triglycerides)	to detect triglycerides level as apart of diagnosis of metabolic syndrome	1 year
blood pressure measurement	to detect if patients is hypertinsive or not as apart of diagnosis of metaboic syndrome	1 year
fasting blood suger	measurment of fasting blood suger to detect hyperglycemia as apart of diagnosis of metaboic syndrome	1 year
body mass index	measurement of weight & height to detect body mass index as apart of diagnosis of metaboic syndrome	1 year
protein creatinine ratio	to measure amount of protein in urine as apart of lupus nephritis	1 year
anti nuclear antibody test by IF	this test to diagnose patient as SLE	1 YEAR

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Hahn BH, McMahon MA, Wilkinson A, Wallace WD, Daikh DI, Fitzgerald JD, Karpouzas GA, Merrill JT, Wallace DJ, Yazdany J, Ramsey-Goldman R, Singh K, Khalighi M, Choi SI, Gogia M, Kafaja S, Kamgar M, Lau C, Martin WJ, Parikh S, Peng J, Rastogi A, Chen W, Grossman JM; American College of Rheumatology. American College of Rheumatology guidelines for screening, treatment, and management of lupus nephritis. Arthritis Care Res (Hoboken). 2012 Jun;64(6):797-808. doi: 10.1002/acr.21664. No abstract available.
• Lim SS, Bayakly AR, Helmick CG, Gordon C, Easley KA, Drenkard C. The incidence and prevalence of systemic lupus erythematosus, 2002-2004: The Georgia Lupus Registry. Arthritis Rheumatol. 2014 Feb;66(2):357-68. doi: 10.1002/art.38239.
• 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.
• DUBOIS EL, TUFFANELLI DL. CLINICAL MANIFESTATIONS OF SYSTEMIC LUPUS ERYTHEMATOSUS. COMPUTER ANALYSIS OF 520 CASES. JAMA. 1964 Oct 12;190:104-11. doi: 10.1001/jama.1964.03070150014003. No abstract available.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Insulin Resistance; Hyperinsulinism; Glomerulonephritis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Metabolic Syndrome; Nephritis; Lupus Nephritis
• Other Study ID Numbers: soh-Med-23-07-15MS

Drug and device information, study documents

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