Prognostic Potential of Novel Urinary Biomarkers Combination for Predicting Progression of Diabetic Kidney Disease in Type 2 Diabetes MellitusÂ
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Rapid decline of GFR
研究概览
简要总结
The study aims to observe the predictive potential of the seven urinary biomarkers panel, namely Cystatin C, KIM-1, NGAL, TNF-α, MCP-1, CTGF, and TGF-β in patients with diabetic kidney disease and type 2 diabetes mellitus. In this study, the patients will be recruited from this hospital, and the levels of these seven biomarkers will be measured at the time of recruitment from their urine samples. Further, the patients will be observed for one year for rapid progression of DKD or rapid decline of GFR. The patients will also be monitored for proteinuria, micro- or macro-vascular complications, or even patient mortality.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •All consecutive adult patients (age ≥ 18 years).
- •Clinically Diagnosed with CKD as per KDIGO guidelines (CKD stage 1-3) based on CKD-EPI equation in type 2 DM visiting the out-patient clinics of the department of Nephrology, Endocrinology and Medicine.
排除标准
- •Those with CKD stage 4-5, urinary tract infection, inflammatory disorder, allergic disorder, cancer, autoimmune disorder, CKD plus superimposed with non-DM kidney disease, systemic connective tissue disorder and those under nephrotoxic medication.
结局指标
主要结局
Rapid decline of GFR
时间窗: 1 year
次要结局
- Worsening of proteinuria(1 year)
- Onset of diabetic retinopathy or peripheral neuropathy(6 months)
- Onset of Cardiovascular diseases or coronary artery diseases or peripheral vascular disease(6 months)
- Mortality(1 year)
研究者
Dr Mohan V Bhojaraja
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal