| CTRI Number |
CTRI/2026/01/100023 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Neck Blood Flow to Detect Early Blood Vessel Disease in People with Metabolic Syndrome |
|
Scientific Title of Study
|
Evaluation of Common Carotid Artery Flow Dynamics for Early Diagnosis of Atherosclerosis in Patients with Metabolic Syndrome |
| 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 Delphin Rushma L R |
| Designation |
Post graduate resident |
| Affiliation |
VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE & HOSPITALS |
| Address |
DEPARTMENT OF GENERAL MEDICINE, VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE & HOSPITALS, SALEM.
Salem
TAMIL NADU
636308
India |
| Phone |
8610809866 |
| Fax |
|
| Email |
l.rushma.r@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seetharaman Ranganathan Rangabashyam |
| Designation |
Professor and medical superintendent |
| Affiliation |
Vinayaka missions kirupananda variyar medical college and hospital |
| Address |
Department of General Medicine, OPD NO 16, Vinayaka missions kirupananda variyar medical college and hospital
University- Vinayaka missions research foundation (DU), Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9894187784 |
| Fax |
|
| Email |
rangabashyamsr@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Delphin Rushma L R |
| Designation |
Post graduate resident |
| Affiliation |
VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE & HOSPITALS |
| Address |
DEPARTMENT OF GENERAL MEDICINE, VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE & HOSPITALS, SALEM.
Salem
TAMIL NADU
636308
India |
| Phone |
8610809866 |
| Fax |
|
| Email |
l.rushma.r@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupananda Variayar Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Delphin Rushma L R |
| Address |
ROOM NO.C4 VIPQ GIRIS HOSTEL, VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITAL, NH - 47 SANKARI MAIN ROAD, SEERAGAPADI VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITAL, NH - 47 SANKARI MAIN ROAD, SEERAGAPADI, Salem |
| Type of Sponsor |
Other [Self] |
|
|
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 Delphin Rushma L R |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital |
OPD no. 16, Department of General Medicine, Seeragapadi - 636308
Salem
TAMIL NADU |
8610809866
l.rushma.r@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vianyaka Missions Kirupananda Variyar Medical College and Hospitals, Institutional Ethics Committee, Vinayaka Missions Kirupananda Variyar medical college and hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E889||Metabolic disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of Metabolic Syndrome based on at least three of the following:
Waist circumference greater than 102 cm (men),greater than 88 cm (women)
Fasting blood glucose greater than or equal to 100 mg/dL or on treatment
Blood pressure greater than or equal to130/85 mmHg or on antihypertensive treatment
Triglycerides greater than or equal to 150 mg/dL
HDL cholesterol less than 40 mg/dL (men), less than 50 mg/dL (women)
|
|
| ExclusionCriteria |
| Details |
History of cardiovascular disease (e.g., myocardial infarction, stroke)
T2DM for more than 5 years
Chronic kidney disease or hepatic dysfunction
Known inflammatory or autoimmune diseases
Current smokers or those with recent infections
Patients on lipid-lowering or anti-inflammatory medications that may affect vascular parameters
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Alteration in common carotid artery flow dynamics, specifically,
Resistive Index (RI)
Pulsatility Index (PI) |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
09/01/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is an 18 month hospital based cross sectional observational study conducted in the outpatient department of Vinayaka Mission Kirupananda Variyar Medical College and Hospitals involving approximately 100 adult patients with metabolic syndrome aged 18 to 60 years Patients are selected using non probability consecutive sampling based on standard diagnostic criteria for metabolic syndrome All enrolled patients undergo clinical evaluation anthropometric measurements blood pressure recording and biochemical investigations including fasting glucose and lipid profile High resolution carotid Doppler ultrasound is performed to assess carotid flow parameters and carotid intima media thickness The primary outcome is alteration in carotid artery flow dynamics measured at baseline Secondary outcomes include assessment of carotid intima media thickness correlation of Doppler parameters with individual components of metabolic syndrome and identification of metabolic predictors of early atherosclerotic changes Statistical analysis is performed using SPSS employing descriptive statistics correlation tests and multivariate regression analysis The study aims to establish the clinical utility of carotid Doppler flow indices as early non invasive markers of atherosclerosis and cardiovascular risk stratification in patients with metabolic syndrome |