Role of Triglyceride-Glucose Index and Inflammatory Biomarkers as Prognostic Tools for Progression of Diabetic Nephropathy
Role of Triglyceride-Glucose Index and Inflammatory Biomarkers as Prognostic Tools for Progression of Diabetic Nephropathy: A Cross-Sectional Study
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Diabetic nephropathy (DN) is a major microvascular complication of diabetes and a leading cause of chronic kidney disease and end-stage renal disease worldwide . Approximately 30%-40% of people with diabetes develop DN, although prevalence varies by population and region . Clinically, DN is characterized by persistent albuminuria and progressive decline in glomerular filtration rate, and it is strongly linked to cardiovascular events, premature mortality, and major socioeconomic burden . Global burden estimates for 2021 reported 107.6 million prevalent cases, 477.3 thousand deaths, and rising disability-adjusted life years, underscoring the growing public health impact of DN .
Risk stratification in DN is essential for identifying patients at high risk of progression, guiding surveillance intensity, and enabling timely use of renoprotective therapies . Current management relies mainly on albuminuria and estimated glomerular filtration rate, alongside optimization of glycemic control, blood pressure, renin-angiotensin system blockade, SGLT2 inhibitors, GLP-1 receptor agonists, and mineralocorticoid receptor antagonists . However, these conventional markers have important limitations because albuminuria may appear after substantial renal injury, and some patients experience renal decline without marked albuminuria .
Novel biomarkers increasingly focus on metabolic and inflammatory pathways underlying diabetic nephropathy progression . The triglyceride-glucose (TyG) index has emerged as a simple surrogate of insulin resistance and has shown independent association with DN, while inflammatory markers such as TNF-related pathways and interleukin-6 also appear relevant to progression . Among inflammatory indices, NLR has shown the most consistent association with diabetic nephropathy occurrence and progression, while PLR and SII have also been linked to albuminuria, proteinuria, and renal dysfunction in several studies . Still, the evidence remains limited by cross-sectional and single-center designs, heterogeneity, inconsistent cutoffs, and modest standalone accuracy, so larger multicenter longitudinal studies are needed to validate their incremental prognostic value .
Studietype
Inschrijving (Geschat)
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
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)
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Association between the Triglyceride-Glucose (TyG) index and inflammatory biomarkers (NLR, PLR, SII) with the severity/stage of diabetic nephropathy
Tijdsspanne: Baseline
|
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
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Endocriene systeemziekten
- Mannelijke urogenitale ziekten
- Nier Ziekten
- Urologische ziekten
- Vrouwelijke urogenitale ziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Metabole ziekten
- Glucosemetabolismestoornissen
- Diabetes complicaties
- Voedings- en stofwisselingsziekten
- Suikerziekte
- Diabetische nefropathieën
Andere studie-ID-nummers
- TyG, NLR, PLR, and SII in DN
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .