| 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
|
|
|
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
|
|
|
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. |