| CTRI Number |
CTRI/2025/07/090707 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Triglyceride Glucose index as Cardiovascular biomarker. |
|
Scientific Title of Study
|
Triglyceride Glucose Index (TyG) as a biomarker for predicting the risk of cardiovascular disease among women aged 40-60 years residing in rural field practice area of Belagavi: Cross sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sabhya Thakkar |
| Designation |
Postgraduate Student |
| Affiliation |
J.N Medical College |
| Address |
J.N.M.C
J.N.M.C
Belgaum
KARNATAKA
590010
India |
| Phone |
08168866379 |
| Fax |
|
| Email |
thakkarsabhya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajesh R Kulkarni |
| Designation |
Professor |
| Affiliation |
J.N Medical College |
| Address |
J.N.M.C
Belgaum
KARNATAKA
590010
India |
| Phone |
09886010047 |
| Fax |
|
| Email |
rajesh2kulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajesh R Kulkarni |
| Designation |
Professor |
| Affiliation |
J.N Medical College |
| Address |
J.N.M.C
Belgaum
KARNATAKA
590010
India |
| Phone |
09886010047 |
| Fax |
|
| Email |
rajesh2kulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Community Medicine
J.N.M.C, Belagavi
590010 |
|
|
Primary Sponsor
|
| Name |
Sabhya |
| Address |
J.N.M.C Belagavi
590010 |
| 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 |
| Sabhya Thakkar |
J.N Medical College |
Department of Community Medicine
Belgaum
KARNATAKA |
08168866379
thakkarsabhya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Women between 40-60 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 40-60 years old residing in rural field practice area. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the TyG index as a biomarker for predicting the risk of cardiovascular disease among women aged 40-60 years residing in rural field practice area. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the TYG index as a good biomarker with ASCVD score in predicting the risk of cardiovascular disease |
1 year |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
24/07/2025 |
| 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="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
|
Cardiovascular
diseases (CVDs) are a group of disorders of the heart and blood vessels. They
include coronary heart disease, cerebrovascular disease, peripheral arterial
disease, rheumatic heart disease, congenital heart disease, deep vein thrombosis
and pulmonary embolism.
CVDs
remain the leading cause of disease burden in the world, 6.2 million
death
occurring between the age of 30 to 70 years in 2019.
Atherosclerotic
cardiovascular vascular diseases (ASCVDs) continue to be one of the top causes
of death globally, despite tremendous advancements in their prevention and
treatment. A family history of ASCVDs, age, obesity, hypertension,
hypercholesteremia, and diabetes are established risk factors for ASCVDs.
ASCVD
Risk score can be calculated by using age, sex. Race, SBP, DBP, TC, HDL, LDL
When
forecasting cardiovascular events, the TyG index has been used as a stand-in
marker. TyG index was associated with
progression of carotid arterial stenosis, carotid artery plaques ,
arterial stiffness. TyG index influenced the severity of CVD. TyG index could
predict a risk of multi-vessel lesion.Conversely, the Framingham
risk score (FRS) is a tool that can forecast the likelihood of subsequent
cardiovascular events based on the existence or lack of specific risk factors.
|