- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07813793
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
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 .
Tipo di studio
Iscrizione (Stimato)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Group A: patients with diabetes mellitus without diabetic nephropathy
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Group B: patients with early-stage DN (Stage 1, Stage 2, and Stage 3a)
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Group C: patients with advanced-stage DN (Stage 3b, Stage 4, Stage 5 not on dialysis)
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Association between the Triglyceride-Glucose (TyG) index and inflammatory biomarkers (NLR, PLR, SII) with the severity/stage of diabetic nephropathy
Lasso di tempo: Baseline
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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.
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Baseline
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Collaboratori e investigatori
Sponsor
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie del sistema endocrino
- Malattie urogenitali maschili
- Malattie renali
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattie metaboliche
- Disturbi del metabolismo del glucosio
- Complicanze del diabete
- Malattie nutrizionali e metaboliche
- Diabete mellito
- Nefropatie diabetiche
Altri numeri di identificazione dello studio
- TyG, NLR, PLR, and SII in DN
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .