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
Visão geral do estudo
Status
Condições
Descrição detalhada
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 de estudo
Inscrição (Estimado)
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
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)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Association between the Triglyceride-Glucose (TyG) index and inflammatory biomarkers (NLR, PLR, SII) with the severity/stage of diabetic nephropathy
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças do Sistema Endócrino
- Doenças Urogenitais Masculinas
- Doenças renais
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doenças Metabólicas
- Distúrbios do Metabolismo da Glicose
- Complicações do Diabetes
- Doenças Nutricionais e Metabólicas
- Diabetes Mellitus
- Nefropatias Diabéticas
Outros números de identificação do estudo
- TyG, NLR, PLR, and SII in DN
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .