Role of Triglyceride-Glucose Index and Inflammatory Biomarkers as Prognostic Tools for Progression of Diabetic Nephropathy

NCT07813793 | Not Yet Recruiting

• 1 other identifier: TyG, NLR, PLR, and SII in DN
• Study Type: observational
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the prognostic value of the Triglyceride-Glucose (TyG) index alongside inflammatory biomarkers in predicting the progression of diabetic nephropathy, exploring their correlation with disease severity to identify accessible, cost-effective markers for early risk stratification and clinical monitoring in diabetic patients.

Conditions

Diabetes Mellitus; Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

• Association between the Triglyceride-Glucose (TyG) index and inflammatory biomarkers (NLR, PLR, SII) with the severity/stage of diabetic nephropathy

  To evaluate the association between the Triglyceride-Glucose (TyG) index and inflammatory biomarkers (NLR, PLR, SII) with the severity/stage of diabetic nephropathy (based on eGFR and UACR categories, per KDIGO classification), and to determine their diagnostic/prognostic accuracy (sensitivity, specificity, AUC via ROC analysis) in identifying patients at higher risk of DN progression.

  Baseline

Study Arms (3)

Group A: patients with diabetes mellitus without diabetic nephropathy

Group B: patients with early-stage DN (Stage 1, Stage 2, and Stage 3a)

Group C: patients with advanced-stage DN (Stage 3b, Stage 4, Stage 5 not on dialysis)

Eligibility Criteria

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

Study Population

Adult patients (≥18 years) with type 1 or type 2 diabetes mellitus, with or without diabetic nephropathy.

You may qualify if:

• Adult patients (≥18 years).
• Patients diagnosed with Type 2 or Type 1 Diabetes Mellitus.
• Patients accepted to provide informed consent and available for clinical examination, blood sampling, and completion of required laboratory investigations (Triglyceride level, fasting glucose, inflammatory markers).

You may not qualify if:

• Patients with non-diabetic causes of chronic kidney disease (e.g., glomerulonephritis, polycystic kidney disease, obstructive uropathy).
• Patients with acute kidney injury, active urinary tract infection, or other acute inflammatory/infectious conditions that could confound inflammatory biomarker levels.
• Patients on dialysis or with a history of renal transplantation.
• Patients with conditions known to independently alter triglyceride/glucose levels or hematological parameters (PLR, NLR, SII) were excluded, including uncontrolled thyroid disease, active malignancy, current corticosteroid or immunosuppressive therapy, pregnancy, or severe hepatic dysfunction affecting lipid/glucose metabolism; hematological disorders such as hematological malignancies, or thrombocytopenia/thrombocytosis of nondiabetic origin; active infection, sepsis, and recent blood transfusion or use of medications affecting blood cell counts (e.g., chemotherapy, anticoagulants affecting platelet function).

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: September 5, 2026
• First Posted: September 10, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09