Systemic Immune Inflammation Index With Related Blood Ratios and Platelet Parameters in Patients With Type 2 Diabetes Mellitus and Nephropathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Systemic Immune-Inflammation Index (SII) Level
研究概览
简要总结
Diabetic kidney disease (DKD) is a frequent microvascular complication in individuals with type 2 diabetes mellitus (T2DM) and a major cause of chronic kidney failure worldwide. Chronic low-grade inflammation and platelet activation contribute significantly to renal microvascular damage.
The purpose of this observational study is to evaluate whether routine blood test markers, specifically the Systemic Immune-Inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and platelet indices (such as mean platelet volume [MPV] and platelet distribution width [PDW]), can serve as simple, accessible, and cost-effective biomarkers for identifying the presence and progression of diabetic kidney disease.
Participants will include adult patients with type 2 diabetes categorized according to their urinary albumin-to-creatinine ratio (normoalbuminuria, microalbuminuria, and macroalbuminuria) as well as healthy control subjects. Complete blood counts, derived inflammatory indices, and renal parameters will be measured to assess their diagnostic accuracy for DKD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 80 years, both males and females.
- •Confirmed clinical diagnosis and history of Type 2 Diabetes Mellitus (T2DM).
- •Healthy control subjects matched for age and sex (for the control cohort).
排除标准
- •Type 1 diabetes mellitus.
- •Acute infections or clinical signs of active inflammation at the time of sampling.
- •Chronic inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus).
- •Known or recently diagnosed malignancies.
- •Chronic liver diseases, including cirrhosis or hepatitis.
- •Nephrotic syndrome or other known non-diabetic kidney diseases.
- •History of immunosuppressive therapy, systemic corticosteroids, or cytotoxic medications within the past 3 months prior to enrollment.
- •Pregnancy.
- •Significant cardiovascular complications.
研究组 & 干预措施
T2DM with Normoalbuminuria
30 adult patients diagnosed with type 2 diabetes mellitus presenting with normoalbuminuria, defined as urinary albumin-to-creatinine ratio (uACR) < 30 mg/g creatinine.
T2DM with Microalbuminuria
30 adult patients diagnosed with type 2 diabetes mellitus presenting with microalbuminuria, defined as urinary albumin-to-creatinine ratio (uACR) between 30 and 299 mg/g creatinine.
T2DM with Macroalbuminuria
30 adult patients diagnosed with type 2 diabetes mellitus presenting with macroalbuminuria, defined as urinary albumin-to-creatinine ratio (uACR) ≥ 300 mg/g creatinine.
Healthy Controls
30 age- and sex-matched healthy control individuals without diabetes, renal impairment, or chronic inflammatory disease.
结局指标
主要结局
Systemic Immune-Inflammation Index (SII) Level
时间窗: Baseline
Systemic Immune-Inflammation Index calculated as: Platelet count (10\^9/L) × Neutrophil count (10\^9/L) / Lymphocyte count (10\^9/L).
次要结局
未报告次要终点
研究者
Eman Ali Mohammed Ali
Resident of Clinical Pathology
Assiut University