| CTRI Number |
CTRI/2025/09/094243 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the relation between simple blood counts and markers for control of sugars in adults with Diabetes |
|
Scientific Title of Study
|
The Association between Neutrophil to Lymphocyte Ratio and HbA1C in Glycemic Control in Adult patients with Type 2 Diabetes Mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lekshmi P |
| Designation |
Junior Resident |
| Affiliation |
KMC, Manipal |
| Address |
Department of General Medicine,
KMC,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9061028409 |
| Fax |
|
| Email |
lekshmip99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Weena Stanley |
| Designation |
Associate Professor |
| Affiliation |
KMC, Manipal |
| Address |
Department of General Medicine,
KMC,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202922812 |
| Fax |
|
| Email |
weena.stanley@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lekshmi P |
| Designation |
Junior Resident |
| Affiliation |
KMC, Manipal |
| Address |
Department of General Medicine,
KMC,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9061028409 |
| Fax |
|
| Email |
lekshmip99@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPT OF GENERAL MEDICINE,
KMC, Manipal,
Udupi - 576104
Karnataka,
India |
|
|
Primary Sponsor
|
| Name |
Department of General Medicine |
| Address |
KMC,Manipal
Udupi, 576104
Karnataka |
| 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 Lekshmi P |
KMC, MANIPAL |
OPD block, IP- wards
Department of General Medicine
Udupi
KARNATAKA |
08202922812
lekshmip99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL RESEARCH COMMITTE- STUDENT RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
HbA1C
Neutrophil to Lymphocyte Ratio |
HbA1c
Absolute neutrophil count and Absolute lymphocyte count will be collected from routine standard of care tests like Complete blood count |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Type 2 Diabetes Mellitus attending the General Medicine department |
|
| ExclusionCriteria |
| Details |
Any history of or on current treatment for -Malignancy
Patients on steroids
Thyroiditis
Chronic Kidney Disease
Gestational Diabetics
Acute infections in past 2 weeks
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Strength of association between HbA1C and NLR will be estimated by calculating the Pearson correlation coefficient.
|
at baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Covariates that are significantly associated will be identified & Odds Ratios estimated. |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="97"
Sample Size from India="97"
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)
|
15/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM: To elucidate the potential relationship between Neutrophil Lymphocyte Ratio (NLR) and HBA1c in adult patients with T2DM and to identify factors that influence the correlation between HbA1c and Neutrophil to Lymphocyte. Objectives 1. To determine the relationship between glycemic control as measured by HbA1c and Neutrophil to Lymphocyte ratio in adult patients with type 2 diabetes mellitus (T2DM) 2. To estimate the strength of association using Pearson correlation coefficient between glycemic control as measured by HbA1c and Neutrophil to Lymphocyte ratio in adult patients with type 2 diabetes mellitus (T2DM) 3. To identify factors that are significantly associated with HbA1c and Neutrophil to Lymphocyte ratio in the study patients.
Reports will be obtained from medical records.
Patients are recruited from OPD/IP of those attending the Dept of General Medicine Proforma will be provided for gathering data.
Statistical analysis will be done using Pearson’s coefficient of correlation as well as covariate measurements will be done for analysis.
|