Effects of GLP-1 Agonist and SGLT2 Inhibitor on Cardiovascular Health in Diabetic Patients
The Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination on Endothelial Function, Arterial Stiffness and Left Ventricular Deformation in Patients With Type 2 Diabetes With High Cardiovascular Risk
This study is testing how two types of diabetes medications can improve heart health in people with type 2 diabetes who are at high risk for heart problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | University of Athens Academic / other |
| Locations | 1 site (Athens, Attica) |
| Trial ID | NCT03878706 on ClinicalTrials.gov |
What this trial studies
This observational study examines the cardiovascular effects of GLP-1 agonists and SGLT2 inhibitors in patients with type 2 diabetes mellitus who are at high cardiovascular risk or have heart failure with preserved ejection fraction. It involves four groups of patients receiving different combinations of diabetes medications over a 12-month period. The study aims to assess changes in endothelial glycocalyx integrity, oxidative stress biomarkers, arterial stiffness, and other cardiovascular indicators. Participants will be monitored at baseline, 6 months, and 12 months to evaluate the effectiveness of the treatments.
Who should consider this trial
Good fit: Ideal candidates are individuals with type 2 diabetes mellitus who have high or very high cardiovascular risk or heart failure with preserved ejection fraction.
Not a fit: Patients with type 1 diabetes mellitus, kidney disease, or retinopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular outcomes for patients with type 2 diabetes.
How similar studies have performed: Other studies have shown promising results with similar combinations of diabetes medications, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject has type 2 diabetes mellitus * Subject has high or very high cardiovascular risk * Subject has heart failure with preserved ejection fraction Exclusion Criteria: * Subject has type 1 diabetes mellitus * Subject has kidney disease * Subject has retinopathy
Where this trial is running
Athens, Attica
- "Attikon" University General Hospital — Athens, Attica, Greece (Recruiting)
Study contacts
- Principal investigator: Ignatios Ikonomidis, Prof — 2nd Department of Cardiology, National and Kapodistrian University of Athens
- Study coordinator: Ignatios Ikonomidis, Prof.
- Email: ignoik@gmail.com
- Phone: 00306944805732
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.