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CTRI Number  CTRI/2022/09/045975 [Registered on: 28/09/2022] Trial Registered Prospectively
Last Modified On: 16/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study of Functioning of nerves in people with Diabetes 
Scientific Title of Study   Study of Nerve Conduction Parameters in Subjects with Type-II Diabetes Mellitus-A Cross Sectional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vandana Indraprakash Pattni 
Designation  Associate Professor 
Affiliation  Merchant Physiotherapy college 
Address  Merchant Physiotherapy college Merchant Education campus Mehsana Visnagar highway Basna Mehsana Gujarat 384315
Merchant Physiotherapy college Merchant Education campus Mehsana Visnagar highway Basna Mehsana Gujarat 384315
Mahesana
GUJARAT
384002
India 
Phone  9429033007  
Fax    
Email  vandanapattni2989@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Hardini Prajapati 
Designation  Senior lecturer and PG Guide 
Affiliation  Gujarat University 
Address  Ahemdabad Institute of Medical Sciences College of Physiotherapy Affiliated to Gujarat University
Ahemdabad Institute of Medical Sciences College of Physiotherapy Affiliated to Gujarat University
Ahmadabad
GUJARAT
380060
India 
Phone  9898550634  
Fax    
Email  drhardini@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Vandana Indraprakash Pattni 
Designation  Associate Professor 
Affiliation  Merchant Physiotherapy college 
Address  Merchant Physiotherapy college Merchant Education campus Mehsana Visnagar highway Basna Mehsana Gujarat 384315
Merchant Physiotherapy college Merchant Education campus Mehsana Visnagar highway Basna Mehsana Gujarat 384315
Mahesana
GUJARAT
384002
India 
Phone  9429033007  
Fax    
Email  vandanapattni2989@gmail.com  
 
Source of Monetary or Material Support  
Sadbhav Neurodiagnostic and Physiotherapy Clinic Mehsana Gujarat 
 
Primary Sponsor  
Name  Vandana Indraprakash Pattni 
Address  18 Paras society Opposite Food Corporation Of India (FCI) godown Modhera road Mehsana 384002 
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 
Ketul Oza  Sadbhav Neurodiagnostic and Physiotherapy Clinic  third floor Om Complex Radhanpur road Near Patel Jewellers (Mehsanawala) Mehsana 384002
Mahesana
GUJARAT 		 9979272272

ketul112_oza@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sadbhav Neurodiagnostic And Physiotherapy Clinic  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects diagnosed with Type-II Diabetes mellitus (as per WHO criteria)
willing and capable of providing consent 
 
ExclusionCriteria 
Details  Subjects with type-I Diabetes
Chronic alcoholic
cerebrovascular stroke
peripheral neuropathy due to some other known cause
peripheral arterial disease or evidence of limb ischemia
subjects who refuse to give consent
skin lesion or swelling which could interfere with Nerve conduction study
trauma in the course of the nerve to be examined 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
nerve conduction parameters to be studied will include Compound motor action potential (CMAP) amplitude in millivolt
Sensory nerve action potential (SNAP) amplitude in microvolts
nerve conduction velocity (NCV) in metre/second
Bilateral Median, Ulnar, Tibial, Peroneal, Sural, superficial peroneal, median sensory and Ulnar sensory nerves will be studied 		 One time study 
 
Secondary Outcome  
Outcome  TimePoints 
correlation of Nerve conduction parameters with Duration of Diabetes, level of HbA1c, Body mass index.
Differences in nerve conduction parameters between Males and females 		 one time 
 
Target Sample Size   Total Sample Size="163"
Sample Size from India="163" 
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)   01/10/2022 
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   not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is a cross-sectional study in which nerve conduction parameters of Bilateral Median, Ulnar, Tibial and common peroneal motor nerves; and Bilateral Median, Ulnar, Sural and Superficial peroneal sensory nerves will be recorded using RMS EMG SALUS software. Appropriate statistical test and software will be utilized for analysis. 
 The above parameters will then be correlated with Duration of diabetes, HbA1c levels and Body mass index values. Also, the parameters will be compared between males and females to determine any gender effect.
This study will be helpful to the society in terms of providing objective Diabetic Peripheral Neuropathy (DPN) measurements, analysis of various factors that could alter the disease process . Timely diagnosis of DPN  will definitely aid in prevention of it’s deadly complications. This would ultimately result in improved quality of life and reduction in health costs.

 
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