| CTRI Number |
CTRI/2024/03/064038 [Registered on: 12/03/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Predictive value of triglyceride glucose index, hemoglobin glycation index and glycemic gap in the outcome of heart attacks in diabetic patients |
|
Scientific Title of Study
|
Association of triglyceride glucose index, hemoglobin glycation index and glycemic gap in Type 2 Diabetes Mellitus patients with Acute coronary syndrome - An observational 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 |
Thejus Suresh |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Hospital, Kasturba Medical College, Madhav Nagar, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9632144058 |
| Fax |
|
| Email |
drthejusuresh@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shivashankar KN |
| Designation |
Professor & Head of Unit, Department of General Medicine |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Hospital, Kasturba Medical College, Madhav Nagar, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9448623861 |
| Fax |
|
| Email |
shi.sha@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Shivashankar KN |
| Designation |
Professor & Head of Unit, Department of General Medicine |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Hospital, Kasturba Medical College, Madhav Nagar, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9448623861 |
| Fax |
|
| Email |
shi.sha@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital Manipal |
|
|
Primary Sponsor
|
| Name |
Dr Thejus Suresh |
| Address |
Department of General Medicine, Kasturba Hospital, Kasturba Medical College, Madhav Nagar, Manipal, Karnataka - 576104 |
| 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 Thejus Suresh |
Kasturba Hospital Manipal |
Department of General Medicine Kasturba Medical College Manipal Udupi KARNATAKA |
9632144058
drthejusuresh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL as it is an observational study |
| Comparator Agent |
NIL |
Nil as it is an observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All type 2 diabetes mellitus patients diagnosed as per ADA criteria
Type 2 diabetes patients who have been diagnosed with Acute coronary syndrome as per AHA updated guidelines for the diagnosis of acute coronary syndrome |
|
| ExclusionCriteria |
| Details |
Patients with the following:
Cardiomyopathy
Valvular Heart Disease
Hemolytic Anemia
Chronic Kidney Disease
Nephrotic Syndrome
Chronic Liver Disease/severe hepatic dysfunction
Hypothyroidism
Suspected familial hypertriglyceridemia or one first-degree relative with hypertriglyceridemia
Patients taking statins and triglyceride - lowering medications before the onset of ACS |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between Triglyceride - glucose index, hemoglobin glycation index and glycemic gap with the outcome of Acute coronary syndrome in Type 2 Diabetes Mellitus |
Baseline at the time of recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="217" Sample Size from India="217"
Final Enrollment numbers achieved (Total)= "219"
Final Enrollment numbers achieved (India)="219" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/03/2024 |
| Date of Study Completion (India) |
11/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Need for Study:
HbA1c, Fasting Glucose levels and Fasting triglyceride levels are important lab values that are commonly sent for diabetic patients both in outpatient as well as inpatient settings.
ACS occurs earlier in diabetics and is associated with increased mortality and a higher risk of recurrent ischemic events. An increased pro-inflammatory and pro-thrombotic state is involved in the poorer outcomes of diabetic patients. As such, it is important to have markers for early detection and treatment of ACS in diabetics to improve the outcome
Due to the closely linked nature of diabetics and ACS, the indices being analysed in the study could prove important in providing important prognostic data, at a very easily accessible and affordable level, as these tests are done routinely.
Data is currently limited on the use of these indices as prognostic markers for ACS.
Description:
Patients who fit the study inclusion criteria are selected and explained about the study and enrolled after giving informed consent. No identifying data will be recorded in the study.
The following indices are measured: HbA1c, fasting triglyceride and fasting plasma glucose are measured. A1c derived average glucose (ADAG) and predicted HbA1c will be calculated following which Triglyceride-glucose index, hemoglobin glycation index and glycemic gap are calculated using their respective formulae.
All the required tests are routinely done for these patients.
Outcome of each patient’s condition will be noted and tabulated. Specificity and sensitivity of each indice would be measured and noted down. Using Pearson correlation, the indices will be compared with the outcome of ACS in the patient. Patients with ongoing ACS will be followed up on their outcome based on discharge/death and follow up visits. |