The Effect of SGLT-2 Inhibitors on Epicardial Adipose Tissue and Cardiac Function in T2DM Patients With CAD (EpiCAD)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

Sodium-glucose contrasporter-2 (SGLT-2) inhibitors make up an antidiabetic medication that promotes glycosuria. They are known to have an indirect reduction in cardiovascular complications, based on a series of in-depth studies. However, the effect of SGLT-2 inhibitors towards the thickness of epicardial adipose tissue and cardiac function in type 2 diabetes mellitus (T2DM) with coronary artery disease (CAD) patients in Malaysia has not yet been fully explored. Therefore, this study aims to determine the effects in epicardial adipose tissue thickness and its cardiac function in T2DM patients with CAD after the initiation of SGLT-2 inhibitors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Malaysia
Institute for Clinical Research, National Institutes of Health, Malaysia
RECRUITING
Shah Alam
Contact Information
Primary
Wan Ahmad Syazani Mohamed, MBBS
syazanimohamed@gmail.com
+60142315940
Backup
Samshol Sukahri, MD
samshol@ummc.edu.my
+60123720477
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 360
Treatments
SGLT-2 inhibitor group
Patients will be given a recommended dose of SGLT-2 inhibitor by cardiologist in a form of tablets based on clinical indication. The SGLT-2 inhibitor includes :~1. Tab Empagliflozin 10mg OD~2. Tab Dapagliflozin 10mg OD~After administration of SGLT-2 inhibitor, the cardiac function and epicardial adipose tissue thickness will be measured (baseline and 6 month) post intervention
Control group
Patient will not be given SGLT-2 inhibitor and continue SOC up to 6 months. The cardiac function and epicardial adipose tissue thickness will be measured (baseline and 6 month) post intervention
Sponsors
Leads: Clinical Research Centre, Malaysia
Collaborators: University of Malaya, Ministry of Health, Malaysia

This content was sourced from clinicaltrials.gov

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