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

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ClinicalTrials.gov Identifier: NCT05964751

Recruitment Status : Not yet recruiting

First Posted : July 28, 2023

Last Update Posted : July 28, 2023

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Mohamed Salah Eldin Ali, Sohag University

Study Description

Brief Summary:

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 .

Condition or disease	Intervention/treatment
Lupus Nephritis	Diagnostic Test: lipid profile Diagnostic Test: fasting blood suger

Study Design

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Study Type :	Observational
Estimated Enrollment :	120 participants
Observational Model:	Case-Control
Time Perspective:	Retrospective
Official Title:	the Association Between Metabolic Syndrome and Its Components With Lupus Nephritis in Systemic Lupus Erythematosus Patients
Estimated Study Start Date :	August 1, 2023
Estimated Primary Completion Date :	August 1, 2024
Estimated Study Completion Date :	August 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Systemic lupus erythematosus

MedlinePlus related topics: Lupus Metabolic Syndrome

Genetic and Rare Diseases Information Center resources: Lupus Nephritis Glomerulonephritis

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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.

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05964751

Contacts

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Contact: mohamed s ali, resident	01015159035	mohamedsalah@med.sohag.edu.eg
Contact: sahar a al-rahman, assistant professor

Locations

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Egypt
Sohag university Hospital
Sohag, Egypt
Contact: Magdy m Amin, professor

Sponsors and Collaborators

Sohag University

More Information

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.

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.

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.

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.

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Responsible Party:	Mohamed Salah Eldin Ali, resident at rheumatology and rehabilitation department, Sohag University
ClinicalTrials.gov Identifier:	NCT05964751
Other Study ID Numbers:	soh-Med-23-07-15MS
First Posted:	July 28, 2023 Key Record Dates
Last Update Posted:	July 28, 2023
Last Verified:	July 2023

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Nephritis Lupus Nephritis Lupus Erythematosus, Systemic Metabolic Syndrome Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Connective Tissue Diseases	Autoimmune Diseases Immune System Diseases Kidney Diseases Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases Glomerulonephritis

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