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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 

 
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