| 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.
|