| CTRI Number |
CTRI/2026/01/100072 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Neck Size in Heart and Metabolic Diseases |
|
Scientific Title of Study
|
Association between Cardiometabolic disease and neck circumference |
| 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 Raman Kumar Sharma |
| Designation |
Professor |
| Affiliation |
Shri Guru Ram Das Institute of Medical Sciences and Research, Amritsar |
| Address |
36-B Kangra Colony Batala Road Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9814290885 |
| Fax |
|
| Email |
ankuramba@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raman Kumar Sharma |
| Designation |
Professor |
| Affiliation |
Shri Guru Ram Das Institute of Medical Sciences and Research, Amritsar |
| Address |
36-B Kangra Colony Batala Road Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9814290885 |
| Fax |
|
| Email |
ankuramba@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Harmandeep Singh |
| Designation |
Junior Resident |
| Affiliation |
Shri Guru Ram Das Institute of Medical Sciences and Research, Amritsar |
| Address |
G-43 Alpha International City, Daburji, G.T. Road Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
7889042663 |
| Fax |
|
| Email |
harman16498@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Medicine |
| Address |
Shri Guru Ram Das Institute of Medical Sciences and Research vallah ,Amritsar ,Punjab ,India 143001 |
| 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 Raman Kumar Sharma |
Department of Medicine |
Department of medicine,Sri Guru Ram Das Institute of Medical Sciences and Research vallah ,Amritsar,Punjab ,143001
Amritsar
PUNJAB |
9814290885
ankuramba@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age greater and equal to 18 with or without cardiometabolic disease |
|
| ExclusionCriteria |
| Details |
1. Presence of neck deformity, thyroid enlargement, cervical lymphadenopathy, surgical scars that preclude accurate neck circumference measurement.
2. Patient with hypothyroidism
3. Current use of systemic glucocorticoids that can alter fat distribution |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate association between neck circumference and presence of cardiometabolic disease |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| |
|
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
12/01/2026 |
| 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
|
To evalutae neck circumference as a simple, non invasive anthropometric marker for identifying individuals at risk of cardimetabolic diseases. It may serve as an alternative measures with better feasibility in clinical and community settings. Early identification through this parameter can help in timely intervention and prevention of complications. Upper body subcutaneous fat- estimated via neck circumference- may contribute to cardiometabolic dysfunction through heightened lipolytic activity, resulting in increased release of free fatty acids, insulin resistance, oxidative stress, and endothelial injury. Accordingly, the present study aims to evaluate the association between neck circumference and cardiometabolic disease. |