Effects of SGLT-2 inhibitors on heart health in diabetes patients with coronary artery disease
The Effect of SGLT-2 Inhibitors on Epicardial Adipose Tissue and Cardiac Function in T2DM Patients With CAD (EpiCAD)
This study looks at how a type of diabetes medication called SGLT-2 inhibitors affects heart health in people with type 2 diabetes and coronary artery disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinical Research Centre, Malaysia Academic / other |
| Locations | 1 site (Shah Alam, Selangor) |
| Trial ID | NCT06128096 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how SGLT-2 inhibitors, a class of antidiabetic medications, affect epicardial adipose tissue thickness and cardiac function in Malaysian patients with type 2 diabetes mellitus (T2DM) and coronary artery disease (CAD). The study aims to gather data on patients who have recently started SGLT-2 inhibitors, focusing on their cardiovascular health and the potential benefits of these medications. By analyzing changes in cardiac function and adipose tissue, the research seeks to provide insights into the broader implications of SGLT-2 inhibitors for managing diabetes-related cardiovascular risks.
Who should consider this trial
Good fit: Ideal candidates are Malaysian adults aged 18 and older with type 2 diabetes and established coronary artery disease who have recently started SGLT-2 inhibitors.
Not a fit: Patients with contraindications to SGLT-2 inhibitors or those with other types of diabetes will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular outcomes for patients with diabetes and coronary artery disease.
How similar studies have performed: Previous studies have indicated positive cardiovascular effects of SGLT-2 inhibitors, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Malaysian patients aged 18 years old and above. * Diagnosed with type 2 diabetes mellitus and not any other types of diabetes. * Established diagnosis of coronary artery disease. \* (see definition below) * Glomerular filtration rate (GFR) \>30ml/min/1.73m2 * Women that are not pregnant or breastfeeding during recruitment. * Initiated with SGLT-2 inhibitors for not more than 3 months before recruitment or initiating SGLT-2 at the time of recruitment. Exclusion Criteria: * Patients that are contraindicated to SGLT-2 inhibitors * Other types of diabetes aside from type 2 diabetes mellitus * Initiated with SGLT-2 inhibitors for more than 3 months * History of diabetes ketoacidosis * History of repeated urinary infections or urogenital infections developed during the study * Glomerular filtration rate (GFR) \< 30ml/min/1.73m2 (Stage 4 and Stage 5 CKD) * Other side effects that required discontinuation of treatment with SGLTs * Patients with poor quality of echocardiogram image * Patients with incomplete data of metabolic syndrome components. * Patients who are not compliant * Patient's refusal to take part in the study * Any clinically significant findings or unstable condition during the screening, medical history, or physical examination that, in the investigator's opinion, would compromise participation in this study. This could include patients with poorly controlled hypertension, asthma, diabetes, or other life-threatening conditions.
Where this trial is running
Shah Alam, Selangor
- Institute for Clinical Research, National Institutes of Health, Malaysia — Shah Alam, Selangor, Malaysia (Recruiting)
Study contacts
- Principal investigator: Wan Ahmad Syazani Mohamed — Institute For Medical Research (IMR), Malaysia
- Study coordinator: Wan Ahmad Syazani Mohamed, MBBS
- Email: syazanimohamed@gmail.com
- Phone: +60142315940
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.