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

NCT07719322 | Not Yet Recruiting

• 1 other identifier: TYG index and CVS risks in LN
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Systemic Lupus Erthematosus (SLE); Lupus Nephritis (LN)

Keywords

triglyceride-glucose index; subclinical atherosclerosis; cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• 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).

  baseline (at enrollment)

Study Arms (2)

SLE without nephritis

SLE with nephritis

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit university hospitals

Asyut, Assuit, Egypt

Location

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

nada abdelsalam nada abdelsalam hassan, MSc

CONTACT

+20 01003562354; nada011450@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: phd student in internal medicine

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)