Role of Triglyceride-Glucose Index and Inflammatory Biomarkers as Prognostic Tools for Progression of Diabetic Nephropathy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial population
Adult patients (≥18 years) with type 1 or type 2 diabetes mellitus, with or without diabetic nephropathy.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
105 Participants
are grouped into 3 trial groupsGroup A: Group A: patients with diabetes mellitus without diabetic nephropathy
Group B: Group B: patients with early-stage DN (Stage 1, Stage 2, and Stage 3a)
Group C: Group C: patients with advanced-stage DN (Stage 3b, Stage 4, Stage 5 not on dialysis)
Trial outcomes
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.
Time frame
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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