FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/093714 [Registered on: 26/08/2025] Trial Registered Prospectively
Last Modified On: 24/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Causes of poor blood sugar control in diabetes patients with coronary artery disease 
Scientific Title of Study   Assessment of risk factors influencing poor glycemic control among type 2 diabetes patients with coronary artery disease: a retrospective 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  Kshama K Chouta  
Designation  PG student  
Affiliation  NGSM Institute of Pharmaceutical Sciences  
Address  Department of Pharmacy Practice,NGSM Institute of Pharmaceutical Sciences, Paneer, Derlakatte

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9353678896  
Fax    
Email  kshamakchouta85@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Roopa Satyanarayan Basutkar  
Designation  Assistant professor G-III 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice,NGSM Institute of Pharmaceutical Sciences, Paneer, Derlakatte

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9047155003  
Fax    
Email  roopa.satyanarayan@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Satyanarayan Basutkar  
Designation  Assistant professor G-III 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice,NGSM Institute of Pharmaceutical Sciences, Paneer, Derlakatte

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9047155003  
Fax    
Email  roopa.satyanarayan@nitte.edu.in  
 
Source of Monetary or Material Support  
Department of pharmacy practice,NGSM Institute of Pharmaceutical Sciences(Nitte Deemed to be University), Paneer, Deralakatte, Mangaluru ,Karnataka-575018 
 
Primary Sponsor  
Name  NGSM Institute of Pharmaceutical Sciences  
Address  Department of pharmacy practice,NGSM Institute of Pharmaceutical Sciences(Nitte deemed to be university), Paneer, Deralakatte, Mangaluru ,Karnataka-575018 
Type of Sponsor  Other [Academic Institute ] 
 
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 
Kshama K Chouta   K S Hegde Charitable Hospital   Department of General Medicine, Cardiology and Endocrinology ,Justice K S Hegde Charitable Hospital ,Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA 
9353678896

kshamakchouta85@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC)  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patients who are diagnosed with type 2 diabetes mellitus with coronary artery disease. Age of the patients are above 18 years. Coronary artery disease should be confirmed by angiography findings only. 
 
ExclusionCriteria 
Details  Patients who are diagnosed with type 1 diabetes,patients who are pregnant, patients who are on dialysis or severe kidney disorders.Patients having history of CABG surgery 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
HbA1c levels   8 months 
 
Secondary Outcome  
Outcome  TimePoints 
Predictors considered in the study are age,gender, blood pressure, estimated GFR, current smoking status,ST segment depression,ST segment elevation,Q waves ,sodium ,Potassium , lipid levels & antidiabetic drugs  8 months 
 
Target Sample Size   Total Sample Size="1080"
Sample Size from India="1080" 
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)   12/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  12/09/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
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  

INTRODUCTION

Diabetes is a major health concern worldwide, with high morbidity, disability, mortality, and impaired quality of life. Glycemic control is the important strategy to reduce complications of type 2 diabetes. About 462 million individuals worldwide are affected with T2DM People those who are affected with T2DM and CAD have higher cardiac risk.

NEED FOR STUDY

T2DM and CAD are frequently coexisting conditions and their combination significantly increases the risk of adverse health outcomes. There is a well-defined relationship between increase HbAlc levels and the incidence of CAD, it is estimated that one third of patients undergoing PCI have T2DM. By identifying the most effective HbA1c management strategies reduces the health care expenses while improving patient outcomes.

OBJECTIVE OF THE STUDY:

To determine the predisposing risk factors of CAD in diabetes patients with HbA1c less than and equal to 7 and HbA1c greater than 7.

METHODOLOGY

The retrospective observational study will be conducted for 8 months. Participants included in the study will be patients above the age of 18 of either gender with T2DM and CAD will be carried out in the Department of General medicine, Endocrinology and Cardiology of Justice K S Hegde Charitable hospital Mangalore. The permission from Institutional Ethics Committee will be obtained before the study.

STATISTICAL ANALYSIS

Qualitative data will be expressed as mean ±SD/Median (IQR). Quantitative data will be expressed as frequency in percentages. Pearson Chi-square test/Fisher exact test will be used to find the association between categorical variables P<0.05 will be considered statistically significant. SPSS software version 29 will be used for statistical analysis.


OUTCOME MEASURES

It is important to identify and analyze the risk factors contributing the development of CAD in patients with poor glycemic control in this population. 

 
Close