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临床试验/CTRI/2019/06/019629
CTRI/2019/06/019629尚未招募不适用

Neutrophil-lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR) as predictive markers for chronic kidney disease in persons with type 2 diabetes

Dr Vignesh Kumar2 个研究点 分布在 1 个国家目标入组 317 人开始时间: 2019年6月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
317
试验地点
2
主要终点
The association of Neutrophil Lymphocyte Ratio and Renal function will be studied.

研究概览

简要总结

Title: Observational cross sectional study to assess neutrophil-lymphocyte ratio and platelet lymphocyte ratio as predictive markers for chronic kidney disease in persons with type 2 diabetesThis study is a observational cross sectional study to assess neutrophil-lymphocyte ratio and platelet lymphocyte ratio as predictive markers for chronic kidney disease in persons with type 2 diabetes. 

This study will be done from March 2019 to September 2020 among patients visiting Dr. TMA Pai Hospital, Udupi and Kasturba Hospital, Manipal. One group of patients will include 144 persons with type 2 diabetes mellitus who have no nephropathy or other complications. The other group will include 173 persons with type 2 diabetes mellitus with diabetic nephropathy associated kidney disease with no other apparent cause for renal failure.

Routine blood investigations such as complete blood counts, liver function tests (LFTs), renal function tests, serum electrolytes, urine routine microscopy, lipid profile, fasting blood sugar (FBS)/postprandial blood sugar (PPBS), glycated hemoglobin (HbA1c), urine microalbumin  will be done and compared with similar data in the same patients more than six months old within the last year. Urine microalbumin should ideally be done on two separate occasions evaluvate the proteinuria status in a patient but for the purpose of this study only one sample will collected afresh and if available date within last 12 months will be taken into account. In addition, Highly sensitive C Reactive Protein(HSCRP) will be done on day of visit.

The association of neutrophil lymphocyte ratio and renal function will be studied. Predictive value of neutrophil lymphocyte ratio for chronic kidney disease in diabetics will be assessed and compared to that of platelet lymphocyte ratio, HSCRP, and urine microalbuminuria.

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

  • Persons with type 2 diabetes without nephropathy or other complications
  • Persons with type 2 diabetes with CKD.

排除标准

  • Patients having low glomerular filtration rate (GFR) without microalbuminuria will be excluded from the study.
  • Patients with type 1 DM
  • Febrile patients/patients with infections including urinary tract infection (UTI), respiratory tract infections, gastrointestinal infection, otitis media, viral hepatitis, parasitic infection, viral infection, tuberculosis, local infection, skin infection, AIDS, pyrexia of unknown origin, and any other infectious disease.
  • Patients with systemic disorder such as cardiovascular disease, chronic liver disease, blood disorders, autoimmune disorders, malignancy, poisoning;
  • Patients on anti-inflammatory drugs, systemic or topical steroids, alcohol;
  • Patients with uncontrolled blood pressure (BP);
  • Patients having diseases affecting urinary protein excretion as nephritic syndrome, urolithiasis, renal insufficiency, renal artery stenosis, dehydration state, and UTI.

结局指标

主要结局

The association of Neutrophil Lymphocyte Ratio and Renal function will be studied.

时间窗: 18 months

Predictive value of Neutrophil Lymphocyte ratio for Chronic Kidney disease in diabetics will be assessed and compared to that of Platelet Lymphocyte ratio, High Sensitive C Reactive Protein, and Urine Microalbuminuria

时间窗: 18 months

次要结局

未报告次要终点

研究者

发起方
Dr Vignesh Kumar
申办方类型
Other [self]

研究点 (2)

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