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

NCT06128096 | Unknown DMC FDA Drug

• 1 other identifier: NMRR ID-22-02966-ENM
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; SGLT-2 Inhibitor; Antidabetic Agent; Cardiac Function; Epicardial Adipose Tissue

Outcome Measures

Primary Outcomes (8)

• Left Ventricular Ejection Fraction

  LVEF in %

  6 months

• Left Ventricular Mass Index

  LVMI in gram

  6 months

• Left Ventricular Filling Pressure Ratio

  E/e in ratio

  6 months

• Left Ventricular End Diastolic Diameter

  LVEDD in centimeter

  6 months

• Left Ventricular End Systolic Diameter

  LVESD in centimeter

  6 months

• Left Ventricular End Diastolic Volume

  LVEDV in mililiter

  6 months

• Left Ventricular End Systolic Volume

  LVESV in mililiter

  6 months

• Epicardial Adipose Tissue

  Thickness of epicardial adipose tissue in milimeter

  6 months

Study Arms (2)

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

Drug: Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor

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

Interventions

Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor DRUG

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.

Also known as: Forxiga (Dapagliflozin), Jardiance (Empagliflozin)

SGLT-2 inhibitor group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients (180 T2DM patients that are using SGLT-2 inhibitors and 180 T2DM patients that are not using SGLT-2 inhibitors) who fulfil the inclusion and exclusion criteria will be recruited from the following sources: 1. UMMC Cardiology and Diabetes out-patient clinics 2. UMMC Cardiology and Endocrinology in-patients (wards) All recruited patients will have echocardiogram done during the day of recruitment. A repeated echocardiogram will be carried out at 6-month post recruitment.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinical Research Centre, Malaysia: lead
• University of Malaya: collaborator
• Ministry of Health, Malaysia: collaborator

Study Sites (1)

Institute for Clinical Research, National Institutes of Health, Malaysia

Shah Alam, Selangor, 40170, Malaysia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

For DNA extraction and RT-PCR (Pharmacogenomic) - Only for 6 months follow up to evaluate pharmacogenomic of treated patients and controls

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

dapagliflozin; empagliflozin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Wan Ahmad Syazani Mohamed

  Institute For Medical Research (IMR), Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wan Ahmad Syazani Mohamed, MBBS

CONTACT

+60142315940; syazanimohamed@gmail.com

Samshol Sukahri, MD

CONTACT

+60123720477; samshol@ummc.edu.my

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: June 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: December 31, 2024
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)