Clinical trial
The Effect of SGLT-2 Inhibitors on Epicardial Adipose Tissue and Cardiac Function in T2DM Patients With CAD (EpiCAD)
Name
NMRR ID-22-02966-ENM
Description
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.
Trial arms
Trial start
2022-06-01
Estimated PCD
2024-06-01
Trial end
2024-12-31
Status
Recruiting
Treatment
Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor
Patients (180 diabetic patients with CAD that are using SGLT-2 inhibitors and 180 diabetic patients with CAD that are not using SGLT-2 inhibitors) who fulfil the inclusion and exclusion criteria will be recruited from the following sources:
UMMC Cardiology and Diabetes out-patient clinics UMMC Cardiology and Endocrinology in-patients (wards)
During the recruitment, patients will do baseline echocardiography in which includes epicardial adipose tissue and cardiac function. The same procedure will be repeated 6 months post intervention.
Arms:
SGLT-2 inhibitor group
Other names:
Forxiga (Dapagliflozin), Jardiance (Empagliflozin)
Size
360
Primary endpoint
Left Ventricular Ejection Fraction
6 months
Left Ventricular Mass Index
6 months
Left Ventricular Filling Pressure Ratio
6 months
Left Ventricular End Diastolic Diameter
6 months
Left Ventricular End Systolic Diameter
6 months
Left Ventricular End Diastolic Volume
6 months
Left Ventricular End Systolic Volume
6 months
Epicardial Adipose Tissue
6 months
Eligibility 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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'For DNA extraction and RT-PCR (Pharmacogenomic) - Only for 6 months follow up to evaluate pharmacogenomic of treated patients and controls'}, 'enrollmentInfo': {'count': 360, 'type': 'ESTIMATED'}}
Updated at
2023-11-24
1 organization
1 product
1 indication
Organization
Clinical Research CentreIndication
Coronary Artery Disease