| CTRI Number |
CTRI/2023/02/049524 [Registered on: 07/02/2023] Trial Registered Prospectively |
| Last Modified On: |
24/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on correlation between thyroid profile and triglyceride glucose index in cardiac patients |
|
Scientific Title of Study
|
correlation between thyroid profile and triglyceride glucose index in cardiac patients - A prospective observational study |
| Trial Acronym |
TYG index |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suma k |
| Designation |
student |
| Affiliation |
narayana hrudayalaya |
| Address |
clinical research department, basement, narayana health institute of cardiac health,bommasandra industrial area, Bangalore
clinical research department, basement, narayana health institute of cardiac health,bommasandra industrial area, Bangalore
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
7204896995 |
| Fax |
|
| Email |
sumak0298@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suma k |
| Designation |
student |
| Affiliation |
narayana hrudayalaya |
| Address |
clinical research department, basement, narayana health institute of cardiac health,bommasandra industrial area, Bangalore
clinical research department, basement, narayana health institute of cardiac health,bommasandra industrial area, Bangalore
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
7204896995 |
| Fax |
|
| Email |
sumak0298@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr vikneswaran G |
| Designation |
consultant clinical research |
| Affiliation |
Narayana health institute of cardiac science |
| Address |
clinical research department, basement, narayana health institute of cardiac health,bommasandra industrial area, Bangalore
clinical research department, basement, narayana health institute of cardiac health,bommasandra industrial area, Bangalore
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
9787649182 |
| Fax |
|
| Email |
vikneswaran.g.dr@narayanahealth.org |
|
|
Source of Monetary or Material Support
|
| Narayana institute of cardiac sciences |
|
|
Primary Sponsor
|
| Name |
Suma k |
| Address |
clinical research department, basement, Narayana institute of cardiac sciences, bommasandra industrial area,Bangalore -560099 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Suma k |
Narayana hrudayalaya institute of allied health science |
Narayana hrudayalaya institute of allied health science,bommasandra industrial area, Bangalore
Bangalore Rural
KARNATAKA |
7204896995
sumak0298@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| narayana health academic ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E038||Other specified hypothyroidism, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.undergoing testing for suspected hypothyroidism
2.willing to provide written consent |
|
| ExclusionCriteria |
| Details |
1.Patients with no lab report on
triglyceride/ glucose levels
2.Patients with known diagnosis of hypothyroidism
on thyroid replacement therapy
3.Patients with history of endocrine disorder
(except diabetes mellitus/ dyslipidemia on
stable dose for 2 months)
4.Patients with history of malignancy
5.Patients on corticosteroids
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| correlation of Triglyceride glucose index with TSH and T4 level |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in TYG index,TSH and T4 |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
13/02/2023 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Final results of the study will be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective observational study to study
correlation between thyroid profile and Triglyceride glucose index (TYG index)
in cardiac patients (n=124) undergoing testing for suspected hypothyroidism.
Patients will be categorized into 3 categories as euthyroid, subclinical
hypothyroidism and overt hypothyroidism based on the thyroid profile.
Correlation between thyroid profile and TYG index will be analyzed using
Pearson/ Spearman correlation test. The difference in TYG index will be
compared between the 3 categories. Patients diagnosed with hypothyroidism
started on thyroxine supplement will be followed for 2 months to study the
change in TYG index. |