| CTRI Number |
CTRI/2020/12/029630 [Registered on: 08/12/2020] Trial Registered Prospectively |
| Last Modified On: |
07/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study Cardiac Autonomic complications in patients with Diabetes and Diabetic Foot |
|
Scientific Title of Study
|
Prevalence Of Cardiac Autonomic Neuropathy In Patients With Diabetes And Diabetic Foot Complications |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarthak Wadhera |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute Of Medical Education And Research |
| Address |
Room No. 22, block F, level 4 , Medicine Office, Nehru Hospital , PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8708350882 |
| Fax |
|
| Email |
sarthakwadhera@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashu Rastogi |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute Of Medical Education And Research |
| Address |
Room No .-16, Block C , Nehru Hospital Extension , PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9781001046 |
| Fax |
|
| Email |
ashuendo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sarthak Wadhera |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute Of Medical Education And Research |
| Address |
Medicine office , level 4 , Block F ,Department of Internal Medicine, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8708350882 |
| Fax |
|
| Email |
sarthakwadhera@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Sector 12 , Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sarthak Wadhera |
Diabetic Foot Lab |
Room no. 4008b, Department of endocrinology ,Block C, New OPD, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
8708350882
sarthakwadhera@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E136||Other specified diabetes mellituswith other specified complications, (2) ICD-10 Condition: E136||Other specified diabetes mellituswith other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
ï‚·Patients diagnosed with Diabetes Mellitus as per ADA diagnostic criterion
ï‚·Patients who are able to perform maneuvers like valsalva and hand grip.
ï‚· Patients who are able to understand and provide an informed signed consent
Patients who are willing to give informed consent to participate in the study. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of Cardiac Autonomic Dysfunction in various spectrum of Diabetes Mellitus |
At baseline( meaning- at the time of recruitment of patient into trial, as it is a cross sectional study , not having serial evaluation / follow up of the patient) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare prevalence of Cardiac Autonomic Dysfunction in three groups , i.e. patients having charcots or foot ulcer ,patients having peripheral neuropathy and patients with diabetes who are having none of above mentioned complications |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="246"
Sample Size from India="246"
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)
|
10/12/2020 |
| 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="0"
Months="5"
Days="26" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cardiac Autonomic Neuropathy is defined as dysfunction in autonomic nervous system which affects baseline heart rate , vasomotor responses , and leads to fluctuations in Blood pressure. Its presence has been associated with long standing Diabetes Mellitus in many previous studies. We have seen that many patients with long standing Diabetes and its complications like Charcot arthroneuropathy develop sudden cardiac death which was attributed to abnormalities in autonomic functions . So, we will divide our patients in 3 groups - one with Diabetes and its complications like Diabetic foot or Charcot foot , one with Diabetes and peripheral neuropathy, one with duration matched patients with Diabetes Mellitus having no complications . We will calculate prevalence of CAN( Cardiac Autonomic Neuropathy) in these groups. |