A study to assess if neutrophil-lymphocyte ratio and platelet-lymphocyte ratio can be used to predict chronic kidney disease in patients with type 2 diabetes.

Not yet recruiting

Conditions: Type 2 diabetes mellitus with kidney complications, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2019/06/019629

Lead Sponsor: Dr Vignesh Kumar

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 317

Inclusion Criteria

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

Exclusion Criteria

Patients having low glomerular filtration rate (GFR) without microalbuminuria will be excluded from the study.
Patients with type 1 DM 3.
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; 5.
Patients on anti-inflammatory drugs, systemic or topical steroids, alcohol; 6.
Patients with uncontrolled blood pressure (BP); 7.
Patients having diseases affecting urinary protein excretion as nephritic syndrome, urolithiasis, renal insufficiency, renal artery stenosis, dehydration state, and UTI.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The association of Neutrophil Lymphocyte Ratio and Renal function will be studied.	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	18 months

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (2): Dr. TMA Pai Hospital
🇮🇳
Udupi, KARNATAKA, India
Kasturba Hospital, Manipal
🇮🇳
Udupi, KARNATAKA, India
Dr. TMA Pai Hospital
🇮🇳Udupi, KARNATAKA, India
Dr Vignesh Kumar
Principal investigator
9884779293
vigneshkumar.r@gmail.com