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CTRI Number  CTRI/2023/09/057374 [Registered on: 11/09/2023] Trial Registered Prospectively
Last Modified On: 08/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Comparative 
Study Design  Other 
Public Title of Study   To compare blood parameters in type 2 diabetes mellitus patients with and without nerve disorders . 
Scientific Title of Study   Comparative study of neutrophil-to-lymphocyte ratio in type 2 diabetes mellitus patients with peripheral neuropathy versus type 2 diabetes mellitus patients without peripheral neuropathy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kashish chaudhary 
Designation  Junior resident 
Affiliation  Guru gobind singh medical college and hospital 
Address  Department of medicine , Guru gobind singh medical college and hospital , Faridkot

Faridkot
PUNJAB
151203
India 
Phone  8901003652  
Fax    
Email  kashishchaudhary22@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sumit pal singh chawla 
Designation  Associate professor 
Affiliation  Guru gobind singh medical college and hospital 
Address  Department of medicine , Guru gobind singh medical college and hospital,Faridkot

Faridkot
PUNJAB
151203
India 
Phone  8146444220  
Fax    
Email  drsumitpsc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sumit pal singh chawla 
Designation  Associate professor 
Affiliation  Guru gobind singh medical college and hospital 
Address  Department of medicine , Guru gobind singh medical college and hospital , Faridkot

Faridkot
PUNJAB
151203
India 
Phone  8146444220  
Fax    
Email  drsumitpsc@gmail.com  
 
Source of Monetary or Material Support  
Guru gobind singh medical college and hospital , Faridkot 
 
Primary Sponsor  
Name  Kashish chaudhary 
Address  Department of medicine , GGSMCH , Faridkot 
Type of Sponsor  Other [self] 
 
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 
Kashish chaudhary  Guru gobind singh medical college and hospital  Department of medicine
Faridkot
PUNJAB 
8901003652

kashishchaudhary22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Thesis and ethics committe guru gobind singh medical college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of type 2 diabetes mellitus of any gender with and without peripheral neuropathy 
 
ExclusionCriteria 
Details  TYPE 1 DIABETES MELLITUS
DIABETIC KETOACIDOSIS , HYPEROSMOLAR NON-KETOTC COMA
CORONARY ARTERY DISEASE , HEART FAILURE
ACTIVE INFECTION OR INFECTION IN LAST ONE MONTH
CANCER
ACCUTE POISONING
BLOOD DISORDERS THAT AFFECT NEUTROPHILS AND LYMPHOCYTES(eg MYELOPROLIFERATIVE DISORDERS AND LEUKEMIA)
SMOKING , SIGNIFICANT ALCOHOL INTAKE(MORE THAN 30g PER DAY IN MALES AND MORE THAN 20g PER DAY IN FEMALES)
MEDICATIONS THAT AFFECT NLR (STEROIDS AND IMMUNOSUPPRESSIVE DRUGS)
HYPOTHYROIDISM
CHRONIC KIDNEY DISEASE
VITAMIN B12 DEFICIENCY
PEOPLE LIVING WITH HIV-AIDS(PLHA)
HISTORY OF AUTOIMMUNE DISORDERS
HISTORY OF BLOOD TRANSFUSION DURING PAST 2 WEEKS
PREGNANCY 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine neutrophil to lymphocyte ratio in type 2 diabetes mellitus patients with and without peripheral neuropathy  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the NLR in type 2 diabetes mellitus patients with & without peripheral neuropathy  Baseline 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   18/09/2023 
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="6"
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   Diabetes mellitus (DM) refers to a group of common metabolic disorders that share the phenotype of hyperglycemia. Several distinct types of DM are caused by a complex interaction of genetic and environmental factors. Depending on the etiology of DM, factors contributing to hyperglycemia include reduced insulin secretion, decreased glucose utilization, and increased glucose production .
DM leads to various complications which can be divided into microvascular (retinopathy, neuropathy, and nephropathy) and macrovascular (coronary artery disease, cerebrovascular disease, and peripheral arterial disease).
Diabetic peripheral neuropathy (DPN) is one of the most common chronic complications of DM. Previous studies have shown that 26.4% of type 2 DM patients are complicated by painful DPN , while up to 50% of the DPN patients may be asymptomatic .
Diabetic peripheral neuropathy is defined as the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes after the exclusion of other causes (3).
Chronic inflammatory process has been shown to play a central role in DPN . Neutrophil-to-lymphocyte ratio (NLR) is a novel and inexpensive marker to reflect many kinds of inflammatory states including diabetes and its microvascular complications.
Diagnosing DPN depends on clinical examination and Nerve Conduction Study (NCS) but only large myelinated nerve fibers injury can be detected by traditional electrophysiological methods. However, development of DPN involves different diameters of peripheral, sensory and motor nerve fibers which creates difficulties for early detection and diagnosis of DPN. Thus, searching for a reliable indicator for early diagnosis is very important.
Studies are lacking which can show consistent relation between NLR and DPN thus, through this study we aim to assess and compare the NLR in type 2 DM patients with and without DPN.

 
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