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CTRI Number  CTRI/2017/03/008089 [Registered on: 14/03/2017] Trial Registered Prospectively
Last Modified On: 10/03/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   TO STUDY THE ROLE OF NEUTROPHIL TO LYMPHOCYTE RATIO AS A MEASURE OF SUGAR CONTROL AS COMPARED TO STANDARD TEST OF GLYHB. 
Scientific Title of Study   EVALUATION OF ROLE OF NEUTROPHIL TO LYMPHOCYTE RATIO AS A MARKER OF INFLAMMATORY STATE AND BLOOD SUGAR CONTROL IN TYPE 2 DIABETES. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IEC 674/2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  POORNIMA S TADKAL 
Designation  JUNIOR RESIDENT 
Affiliation  KASTURBA HOSPITAL 
Address  DEPARTMENT OF MEDICINE,KASTURBA HOSPITAL,MANIPAL,UDUPI.

Gulbarga
KARNATAKA
576104
India 
Phone  9742709600  
Fax    
Email  tadkalpoornima29@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR RAVIRAJA V ACHARYA 
Designation  PROFESSOR OF INTERNAL MEDICINE 
Affiliation  KASTURBA HOSPITAL 
Address  ROOM NO-206,DEPARTMENT OF MEDICINE OFFICE AREA,SHARADA MADHAVA PAI OPD BLOCK,KMCH-MANIPAL.

Udupi
KARNATAKA
576104
India 
Phone  9854571000  
Fax    
Email  rvacharya@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  POORNIMA S TADKAL 
Designation  JUNIOR RESIDENT 
Affiliation  KASTURBA HOSPITAL 
Address  DEPARTMENT OF MEDICINE,KASTURBA HOSPITAL,MANIPAL,UDUPI.

Gulbarga
KARNATAKA
576104
India 
Phone  9742709600  
Fax    
Email  tadkalpoornima29@gmail.com  
 
Source of Monetary or Material Support  
KASTURBA HOSPITAL,MANIPAL UNIVERSITY,MANIPAL,UDUPI. 
 
Primary Sponsor  
Name  KASTURBA HOSPITAL 
Address  KASTURBA HOSPITAL,MADHAV NAGAR,MANIPAL 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR POORNIMA S TADKAL  KASTURBA HOSPITAL  MADHAV NAGAR,MANIPAL,UDUPI-576104
Udupi
KARNATAKA 
9742709600

tadkalpoornima29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KASTURBA HOSPITAL   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  PATIENTS WITH TYPE 2 DIABETES,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients with Type 2 Diabetes admitted in kasturba hospital who have given informed consent. 
 
ExclusionCriteria 
Details  Acute/chronic inflammatory states,acute/chronic kidney disease,chronic liver disease,leukemia,lymphoma,malignancies. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate role of neutrophil to lymphocyte ratio as a marker of inflammatory state and blood sugar control in type 2 diabetes.  NOVEMBER 2018 
 
Secondary Outcome  
Outcome  TimePoints 
To study the association of HsCRP and GlyHb in type 2 diabetes  NOVEMBER 2018 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/03/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="10"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   1).Lou, M., Luo, P., Tang, R., Peng, Y., Yu, S., Huang, W., & He, L. (2015). Relationship between neutrophil-lymphocyte ratio and insulin resistance in newly diagnosed type 2 diabetes mellitus patients. BMC Endocrine Disorders, 15, 9. http://doi.org/10.1186/s12902-015-0002-9 2).Eman Youssef Moursy, Azza Abd El-Kareem Ismael, Reham Fadl Hassan Mouftah, Eglal Saad Ghanem El-Tahan. The Value of Neutrophil Lymphocyte Ratio in Predicting the Degree of Insulin Resistance and β Cell Dysfunction in Type 2 Diabetic Patients. American Journal of Internal Medicine. Special Issue: Different Medical Research from Middle East. Vol. 4, No. 2-1, 2016, pp. 1-4. doi: 10.11648/j.ajim.s.2016040201.11  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Aim-Evaluation of role of neutrophil to lymphocyte ratio as a marker of inflammatory state and blood sugar control in type 2 diabetes.
Objectives-1)To study the association between neutrophil to lymphocyte ratio and GlyHb in Type 2 Diabetes mellitus.2)To study the association of HsCRP and GlyHb in Type 2 Diabetes mellitus.3)To study the association of neutrophil to lymphocyte ratio with HsCRP and GlyHb in Type 2 Diabetes mellitus.
sample size-100.
Description-Patients with Type 2 Diabetes meeting the inclusion/exclusion criteria will be included in the study after taking informed consent.Patients will be asked routine history and physical examination will be done.Tests like FBS,PPBS,GlyHb,absolute neutrophil count,absolute lymphocyte count will be done as standard of care.In this study we will draw an additonal blood sample/residual  blood sample and perform HsCRP on it.
Ethical consideration-the cost estimated with HsCRP is the only test that is not done as a part of standard of care,during the participation of the patient in the study,the cost will be born by the investigator.
Budget and funding source-30,000/- ,KMC Manipal.
Review of literature-patients with T2DM are in a state of low degree of chronic inflammation that induces hypersecretion of inflammatory factors,such as CRP,IL-6,TNF-alfa and MCP-1,which resultsin a constantly elevated neutrophilic granulocyte count.One mechanism by which increased levels of neutrophil could mediate insulin resistance may be through augmented inflammation.The increase in NLR appears to underlie the elevated levels of proinflammation,as evident from the persistent neutrophil activation and enhanced release of neutrophil proteases with T2DM.Lymphocytes are reduced as a result of hyperglycemia in T2DM.Also there is an insufficient proliferation of lymphocytes due to low experession of Il-2 receptor.Neutrophil to lymphocyte ratio is an essential marker of systemic inflammation.CRP produced by liver is acute phase response protein increased during inflammation.Many studies done showed-the HsCRP levels were elevated in diabetic subjects,compared with non diabetic subjects.So,studies have suggested that the ratio can be used as marker of inflammation in T2DM.
 
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