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Non Invasive Assessment of Subclinical Atherosclerosis and Cardiovascular Risk Using TYG Index in Lupus Nephritis

2026年7月18日 更新者:Nada Abdelsalam Hasan、Assiut University

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

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

研究概览

地位

尚未招聘

详细说明

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

研究类型

观察性的

注册 (估计的)

156

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Assuit
      • Asyut、Assuit、埃及
        • Assuit university hospitals
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adults aged ≥18 years Diagnosed as SLE according to the 2019 ACR/EULAR classification criteria for systemic lupus erythematosus including patients with and without Lupus nephritis recruited from Assiut University Hospital,Internal medicine departement, ,Rheumatology and Renal unit(inpatient,_outpatient clinics)

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
SLE without nephritis
SLE with nephritis

研究衡量的是什么?

主要结果指标

结果测量
大体时间
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).
大体时间:baseline (at enrollment)
baseline (at enrollment)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2028年7月1日

研究完成 (估计的)

2029年7月1日

研究注册日期

首次提交

2026年7月18日

首先提交符合 QC 标准的

2026年7月18日

首次发布 (实际的)

2026年7月22日

研究记录更新

最后更新发布 (实际的)

2026年7月22日

上次提交的符合 QC 标准的更新

2026年7月18日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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