| 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
|
|
|
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
|
|
|
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. |