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

Официальное название

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

Обзор

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

Подробное описание

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

Первичные конечные точки

• 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). [Срок оценки: baseline (at enrollment)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Египет · 1 центр

• Assuit university hospitals — Asyut

Идентификаторы

NCT: NCT07719322 · TYG index and CVS risks in LN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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