| CTRI Number |
CTRI/2026/03/105259 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find whether Nerve damage in the hands and feet is related to heart nerve problems in people with Type 2 Diabetes |
|
Scientific Title of Study
|
A Study of the correlation between Diabetic Peripheral Neuropathy and Cardiac Autonomic Neuropathy in patients with Type 2 Diabetes Mellitus
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kuchkar Snehal Sanjay |
| Designation |
Post Graduate General Medicine |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital |
| Address |
Department of General Medicine, Vinayaka Missions Kirupananda Variyar Medical College and Hospital Salem
Salem
TAMIL NADU
636308
India |
| Phone |
09420395199 |
| Fax |
|
| Email |
snehalkuchkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Moogaambiga |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital |
| Address |
Department of General Medicine, Vinayaka Missions Kirupananda Variyar Medical College and Hospital Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9842459677 |
| Fax |
|
| Email |
mooks.stanlean@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kuchkar Snehal Sanjay |
| Designation |
Post Graduate General Medicine |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital |
| Address |
Department of General Medicine, Vinayaka Missions Kirupananda Variyar Medical College and Hospital Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9420395199 |
| Fax |
|
| Email |
snehalkuchkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Mission Kirupananda Variyar Medical College and Hospital Salem Tamilnadu 636308 |
|
|
Primary Sponsor
|
| Name |
Dr Kuchkar Snehal Sanjay |
| Address |
Vinayaka Missions KIrupananda Variyar Medical College and Hospital Salem Tamilnadu 636308 |
| 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 |
| Dr Kuchkar Snehal Sanjay |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital Salem |
Department of General Medicine, Vinayaka Missions Kirupananda Variyar Medical College and Hospital Salem
Salem
TAMIL NADU |
09420395199
snehalkuchkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vinayaka Missions Kirupananda Variyar Medical College and Hospital Salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E084||Diabetes mellitus due to underlying condition with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged more than 30 years diagnosed with type 2 diabetes mellitus according to ADA
criteria
Duration of diabetes equal to or more than 5 years
Availability of recent baseline labs within 3 months including HbA1c and serum
creatinine
Patients who provide written informed consent to participate in the study
Patients who are able to undergo detailed neurological and cardiac autonomic function
assessments |
|
| ExclusionCriteria |
| Details |
Patients with type 1 diabetes mellitus
History of coronary artery disease congestive heart failure or significant valvular
heart disease
Known neurological disorders unrelated to diabetes eg stroke multiple sclerosis
Parkinsons disease
Patients with severe renal impairment eg eGFR less than 30 mLmin1.73 m²
Patients with severe hepatic dysfunction
Presence of chronic alcohol use which can cause independent neuropathy Patients on
medications known to affect autonomic function eg beta blockers certain
antidepressants
Active malignancy or current chemotherapy known to cause neuropathy eg
platinum agents taxanes vinca alkaloids within the past 6 to 12 months
Known hereditary neuropathy eg Charcot Marie Tooth or family history
suggesting inherited neuropathy.
Patients with history of chronic occupational or toxic exposure known to cause
peripheral neuropathy eg heavy metals such as lead arsenic mercury
Patients with Vitamin B12 deficiency
Pregnant females |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the correlation between the severity of Diabetic Peripheral Neuropathy and the presence or severity of Cardiac Autonomic Neuropathy in patients with Type 2 Diabetes Mellitus at a single point of assessment |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Prevalence of Cardiac Autonomic Neuropathy in patients with Diabetic Peripheral Neuropathy
Association between duration of Type 2 Diabetes Mellitus and severity of Cardiac Autonomic Neuropathy |
12 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/03/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Type 2 Diabetes Mellitus is commonly associated with microvascular complications including diabetic peripheral neuropathy and cardiac autonomic neuropathy While peripheral neuropathy is frequently diagnosed based on clinical symptoms and examination cardiac autonomic neuropathy often remains subclinical and underdiagnosed despite its association with increased cardiovascular morbidity and mortality Early detection of cardiac autonomic dysfunction in patients with diabetic peripheral neuropathy may help in identifying high risk individuals and preventing adverse cardiovascular outcomes However the correlation between diabetic peripheral neuropathy and cardiac autonomic neuropathy in patients with type 2 diabetes mellitus is not clearly established in the local population This cross sectional observational study aims to assess the prevalence of cardiac autonomic neuropathy in patients with type 2 diabetes mellitus and to determine its correlation with diabetic peripheral neuropathy Peripheral neuropathy will be assessed using validated clinical scoring systems and cardiac autonomic function will be evaluated using standard autonomic function tests The findings of this study may help in early identification of patients at risk and guide timely intervention |