Status:
UNKNOWN
The Effect of SGLT-2 Inhibitors on Epicardial Adipose Tissue and Cardiac Function in T2DM Patients With CAD (EpiCAD)
Lead Sponsor:
Clinical Research Centre, Malaysia
Collaborating Sponsors:
University of Malaya
Ministry of Health, Malaysia
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief 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...
Detailed Description
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder affecting at least 90% of the population with diabetes globally (Bhupathiraju \& Hu, 2016). T2DM is a disorder characterized insulin res...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT06128096
Start Date
June 1 2022
End Date
December 31 2024
Last Update
November 24 2023
Active Locations (1)
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1
Institute for Clinical Research, National Institutes of Health, Malaysia
Shah Alam, Selangor, Malaysia, 40170