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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
PATIENTS WITH TYPE 2 DIABETES, |
|
Intervention / Comparator Agent
|
|
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. |