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CTRI Number  CTRI/2024/01/062039 [Registered on: 30/01/2024] Trial Registered Prospectively
Last Modified On: 24/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Nerve conduction study in Type 2 diabetes patients without sensory symptoms 
Scientific Title of Study   Nerve conduction study of medial plantar and lateral plantar in Type 2 diabetes mellitus patients without sensory symptoms visiting a tertiary care hospital 
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 Nishant Yadav 
Designation  Senior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Room No 11, Department of Neurology, Kasturba hospital, Tiger circle road, Madhava Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9045769051  
Fax    
Email  yadavnishant14@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nikith A 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Kasturba Medical College, Manipal 
Address  Room No 11, Department of Neurology, Kasturba hospital, Tiger Circle Road, Madhava Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9964667280  
Fax    
Email  dr.nikith@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nikith A 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Kasturba Medical College, Manipal 
Address  Room No 11, Department of Neurology, Kasturba hospital, Tiger Circle Road, Madhava Nagar, Manipal


KARNATAKA
576104
India 
Phone  9964667280  
Fax    
Email  dr.nikith@gmail.com  
 
Source of Monetary or Material Support  
Department of Neurology, Kasturba Hospital, Tiger circle road, Madhava Nagar, Manipal Udupi KARNATAKA  
 
Primary Sponsor  
Name  Dr. Nishant Yadav 
Address  Room no 11, Department of Neurology, Kasturba Hospital, Tiger circle road, Madhava Nagar Manipal, 576104 
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 
Dr Nikith A  Kasturba Medical College  Room no 11, Department of Neurology, Kasturba Hospital, Tiger cirlce road, Madhava Nagar, Manipal
Udupi
KARNATAKA 
9964667280

dr.nikith@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.All Type 2 diabetes mellitus patients visiting the department of Neurology, General Medicine and Endocrinology in whom no neuropathic symptoms have started yet.
2.Age must be above 18 years.
 
 
ExclusionCriteria 
Details  1.Patients with diagnosis of type 2 diabetes mellitus with sensory neuropathy.
2.Patients with other causes of peripheral neuropathies .
3.Pregnant and lactating women. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the nerve conduction study parameters of distal sensory nerves of the lower extremities namely, the medial plantar nerve and lateral plantar nerve in Type 2 diabetes mellitus patients with no sensory symptoms and healthy control  February 2023 to January 2025  
 
Secondary Outcome  
Outcome  TimePoints 
To assess if medial and lateral plantar nerve NCS increases the sensitivity in the detection of neuropathy in asymptomatic Type 2 diabetes mellitus patients.  February 2023 to january 2025 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="150" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2024 
Date of Study Completion (India) 31/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

      Diabetic peripheral neuropathy is one of the most common long-term complications of diabetes mellitus and is the main initiation factor for foot ulceration and lower extremity amputation. Proper detection is important because once these changes begin, no known treatment can arrest, prevent or slow the development of neuropathy. Current guidelines suggest that a combination of symptoms, signs, and electrophysiologic measurements provide the most accurate diagnosis. The neuropathic changes may develop well before symptoms are manifested and objective tests which can identify it during its early stages are of prime importance. Nerve conduction study (NCS) is considered the gold standard or a consistent indicator of neuropathy. The typical diabetic peripheral neuropathy is length-dependent and changes begin at the distal nerves affecting the sensory nerves of the lower extremities first. The standard NCS protocol involves sensory NCS of the lower extremity sensory nerves mainly the sural and superficial peroneal nerves along with motor NCS of the peroneal and tibial nerves. However, even with normal NCS findings from conventional studies, NCS changes are evident in the most distal portions of nerves - the lateral plantar and medial plantar nerves. These nerves are the distal nerve endings of the superficial peroneal, sural, and tibial nerves. Because routine NCSs do not assess these distal nerves, some studies have advocated the assessment of these nerves in those with normal NCS findings to increase the diagnostic sensitivity of NCSs. This study will be a screening tool to detect early diabetic neuropathy in diabetes mellitus patients without sensory symptoms.

 
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