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CTRI Number  CTRI/2019/10/021742 [Registered on: 22/10/2019] Trial Registered Prospectively
Last Modified On: 19/10/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   How many people with diabetic peripheral neuropathy have cardiac autonomic neuropathy? 
Scientific Title of Study   AUTONOMIC NEUROPATHY IN PATIENTS WITH DIABETIC PERIPHERAL NEUROPATHY: 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  POONAM ASHOK KAMATH 
Designation  JUNIOR RESIDENT 
Affiliation  KMC, MANIPAL 
Address  Department of General Medicine, KASTURBA HOSPITAL KMC Manipal 576104

Udupi
KARNATAKA
576107
India 
Phone  8317402192  
Fax    
Email  poonamkamath1995@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SUDHA VIDYASAGAR 
Designation  PROFESSOR AND HOU 
Affiliation  KMC, MANIPAL 
Address  DEPARTMENT OF GENERAL MEDICINE, KMC, MANIPAL

Udupi
KARNATAKA
576104
India 
Phone  9880083580  
Fax    
Email  vsagar33@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  POONAM ASHOK KAMATH 
Designation  JUNIOR RESIDENT 
Affiliation  KMC, MANIPAL 
Address  Deaprtment of General Medicine, KASTURBA HOSPITAL KMC Manipal 576104

Udupi
KARNATAKA
576104
India 
Phone  8317402192  
Fax    
Email  poonamkamath1995@gmail.com  
 
Source of Monetary or Material Support  
KASTURBA MEDICAL COLLEGE, MANIPAL 
 
Primary Sponsor  
Name  KASTURBA MEDICAL COLLEGE 
Address  MADHAVA NAGAR, MANIPAL 576104 
Type of Sponsor  Private medical college 
 
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 POONAM KAMATH  KASTURBA HOSPITAL  DEPARTMENT OF GENERAL MEDICINE
Udupi
KARNATAKA 
8317402192

poonamkamath1995@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: E00-E89||Endocrine, nutritional and metabolic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diabetic peripheral neuropathy(with h/o diabetes and symptoms and/or signs of diabetic peripheral neuropathy), NCV 
 
ExclusionCriteria 
Details  Patients taking beta blockers, clonidine, prazosin, steroids, ohenytoin, cisplatin, vincristine, amiodarone, fluoroquinolones, metronidazole, isoniazid, nitrofurantoin
chronic kidney disease
h/o significant alcohol intake
vitamin b12 deficiency
HIV
Severe systemic disease(cardiac, pulmonary, malignancy)
Unstable patient(A/E COPD, Bronchial asthma, severe HTN, ECG s/o myocardial ischemia or infarct) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of autonomic neuropathy in patients who have diabetic peripheral neuropathy  3 years 
 
Secondary Outcome  
Outcome  TimePoints 
Autonomic dysfunction stages correlation with various types of diabetic peripheral neuropathy and their severity
Autonomic dysfunction correlation with hypoglycemia and neuroglycopenia 
2 years 
 
Target Sample Size   Total Sample Size="233"
Sample Size from India="233" 
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)   26/10/2019 
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 published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a cross sectional study where patients with diabetic peripheral neuropathy admitted in medicine ward (with symptoms and/signs of neuropathy) will be recruited and screened for cardiac autonomic neuropathy by the department of physiology.
 
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