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

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05964751
Collaborator
(none)
120
1
12
10

Study Details

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 Phase
  • Diagnostic Test: lipid profile
  • Diagnostic Test: fasting blood suger

Study Design

Study Type:
Observational
Anticipated 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
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm 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

  1. lipid profile (triglycerides) [1 year]

    to detect triglycerides level as apart of diagnosis of metabolic syndrome

  2. blood pressure measurement [1 year]

    to detect if patients is hypertinsive or not as apart of diagnosis of metaboic syndrome

  3. fasting blood suger [1 year]

    measurment of fasting blood suger to detect hyperglycemia as apart of diagnosis of metaboic syndrome

  4. body mass index [1 year]

    measurement of weight & height to detect body mass index as apart of diagnosis of metaboic syndrome

  5. protein creatinine ratio [1 year]

    to measure amount of protein in urine as apart of lupus nephritis

  6. anti nuclear antibody test by IF [1 YEAR]

    this test to diagnose patient as SLE

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Sohag university Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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:
Jul 28, 2023
Last Update Posted:
Jul 28, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2023