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临床试验/NCT07719322
NCT07719322尚未招募不适用

Non Invasive Assessment of Subclinical Atherosclerosis in Relation to Triglyceride-Glucose (TyG) Index and Cardiovascular Risk in Lupus Nephritis a Single Center study_Assuit University

Assiut University1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2026年7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
156
试验地点
1
主要终点
1.Determining whether TyG index independently predicts subclinical atherosclerosis after adjusting for traditional risk factors in patients of systemic lupus erythematosus (SLE) with or without lupus nephritis(LN).

研究概览

简要总结

Systemic lupus erythematosus (SLE) is a chronic, multisystem autoimmune disease characterized by loss of immune tolerance, autoantibody production, immune complex deposition, and complement activation, resulting in widespread inflammation and organ damage. Renal involvement, known as lupus nephritis (LN), occurs in approximately 40-60% of SLE patients and represents one of the most severe disease manifestations, significantly contributing to morbidity and mortality.Lupus nephritis arises from immune complex deposition in glomerular and tubulointerstitial structures, causing inflammatory and proliferative lesions that can progress to chronic kidney disease or end-stage renal disease. The ISN/RPS classification provides a standardized histopathological framework essential for prognosis and guiding treatment decisions.

In addition to renal complications, patients with SLE and LN are at substantially increased risk of premature cardiovascular disease, which cannot be fully explained by traditional cardiovascular risk factors.Persistent systemic inflammation, endothelial dysfunction, dyslipidemia, and insulin resistance accelerate atherosclerosis in these patients. Subclinical vascular changes, including increased carotid intima-media thickness (CIMT) and carotid plaque formation, often precede overt cardiovascular events, underscoring the importance of early cardiovascular risk assessment The triglyceride-glucose (TyG) index is a validated surrogate marker of insulin resistance, correlating with endothelial dysfunction, subclinical atherosclerosis, and increased CIMT Elevated TyG index may therefore serve as a simple, non-invasive tool for early cardiovascular risk stratification in patients with lupus nephritis

详细描述

the study is asingle center observational study will be conducted at Assiut University Hospital,Internal medicine departement, ,Rheumatology and Renal unit(inpatient,_outpatient clinics) including :Full history taking and thorough clinical examination including:

  • Demographic Information: Collect data on age, gender, duration of illness, and relevant medical history.
  • Body Mass Index (BMI)
  • smoking status and Medications history as (corticosteroids, immunosuppressants and anti lipidemic drugs to be excluded)
  • Clinical Assessment: patients diagnosed as SLE according to 2019 EULAR/ACR classification criteria. and lupus nephritis (LN) , classified according to the 2018 ISN/RPS classification of lupus nephritis.and Assessment of SLE disease activity according to SLEADI-2K score.
  • Laboratory Tests:
  • Combelete blood count (CBC)
  • Lipid profile ( fasting TGS ,total cholesterol, LDL, HDL, VLDL)
  • Fasting blood glucose (mg/Dl)
  • Kidney function test (Serum Creatinine ,blood urea nitrogen)
  • eGFR
  • CRP
  • Erthrocyte sedimentation rate (ESR)
  • Autoantibody Profiles: ANA, anti-dsDNA
  • Complement Levels: C3, C4
  • Urinary protein excretion (24-hour urinary protein )
  • Homocysteine
  • Serum uric acid
  • Renal biobsy

- Indices calculation:

  • Triglyceride-Glucose (TyG) Index
  • The CRP_TYG index _- Carotid Ultrasonography

研究设计

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

入排标准

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

入选标准

  • Adults aged ≥18 years
  • Diagnosis of SLE according to the 2019 ACR/EULAR classification criteria for systemic lupus erythematosus.
  • Lupus nephritis , classified according to the 2018 ISN/RPS classification of lupus nephritis.

排除标准

  • Established cardiovascular disease (MI, stroke, PAD)
  • Diabetes mellitus
  • Hypertension
  • Patient with CKD
  • infections
  • other autoimmune diseases
  • Pregnancy
  • Malignancy
  • chronic liver disease
  • Dyslipidemia
  • Patients on lipid lowering therapy

结局指标

主要结局

1.Determining whether TyG index independently predicts subclinical atherosclerosis after adjusting for traditional risk factors in patients of systemic lupus erythematosus (SLE) with or without lupus nephritis(LN).

时间窗: baseline (at enrollment)

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

Nada Abdelsalam Hasan

phd student in internal medicine

Assiut University

研究点 (1)

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