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
|
|
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
|
|
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.
|