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临床试验/NCT05964751
NCT05964751尚未招募不适用

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

Sohag University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
1
主要终点
blood pressure measurement

研究概览

简要总结

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 .

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

blood pressure measurement

时间窗: 1 year

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

lipid profile (triglycerides)

时间窗: 1 year

to detect triglycerides level as apart of diagnosis of metabolic syndrome

fasting blood suger

时间窗: 1 year

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

body mass index

时间窗: 1 year

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

protein creatinine ratio

时间窗: 1 year

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

anti nuclear antibody test by IF

时间窗: 1 YEAR

this test to diagnose patient as SLE

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Salah Eldin Ali

resident at rheumatology and rehabilitation department

Sohag University

研究点 (1)

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