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
|
|
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
|
|
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. |