Effect of Oral Semaglutide on Epicardial and Pericoronary Adipose Tissues in Type 2 Diabetes After Myocardial Infarction

Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · Aug 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to see if a medication called oral semaglutide can help reduce certain types of fat around the heart and blood vessels in patients with type 2 diabetes who have recently had a heart attack. The study will involve men and women aged 50 and older who were diagnosed with type 2 diabetes and experienced a heart attack more than 2 months but less than 9 months ago. To be eligible, participants should have a body mass index (BMI) between 25 and 40 and must not have been treated with specific diabetes medications recently.

If you participate in this trial, you will undergo a few tests to measure the fat around your heart and blood vessels before and after taking the medication for 180 days. These tests will include advanced imaging techniques to see how effective the treatment is. It’s important to know that the trial is not yet recruiting participants, but it aims to understand whether oral semaglutide can be a beneficial treatment for managing heart health in people with diabetes after a heart attack.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Male or female patient aged 50 years or older at the time of screening, diagnosed with type 2 diabetes and with a previous acute myocardial infarction more than 2 and less than 9 months ago, with the following conditions:
• • 1. Signed Informed Consent Form.
• • 2. BMI ≥ 25 and \< 40 kg/m².
• • 3. The following glucose-lowering agents are permitted: any insulin, insulin analogs, sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, and SGLT-2 inhibitors (iSGLT2).
• • 4. Patients using iSGLT2 will not be excluded because they receive this medication at no cost at InCor with benefits for the treatment of type 2 diabetes. Furthermore, there would be an impact on ethical issues and the control of this prescription in other clinics. Thus, we will list the patients using SGLT2 inhibitors and statistically evaluate the comparison with the group that did not use this medication.
• Exclusion Criteria:
• • 1. Patients with type 1 diabetes.
• • 2. Type 2 diabetes currently or previously treated (within 90 days prior to screening) with any GLP-1RA and DPP-4 inhibitor.
• • 3. Those not properly treated for previously diagnosed hypothyroidism.
• • 4. Diagnosed with NYHA class IV heart failure.
• • 5. Myocardial infarction more than 9 months after diagnosis.
• • 6. Any of the following: myocardial infarction, stroke, or hospitalization for unstable angina or transient ischemic attack within 60 days before screening.
• • 7. Any contraindication present in the package insert for the use of GLP1-RA or Oral Semaglutide.
• • 8. Desire to become pregnant.
• • 9. Previous history of pancreatitis (acute or chronic).
• • 10. Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
• • 11. History of major surgical procedures involving the stomach, potentially affecting the absorption of the test product (e.g., subtotal and total gastrectomy, vertical gastrectomy, gastric bypass surgery).
• • 12. Planned and known coronary, carotid, or peripheral arterial revascularization on the day of screening.
• • 13. Chronic or intermittent hemodialysis, peritoneal dialysis, or severe renal insufficiency (corresponding to eGFR \< 30 mL/min/1.73 m²) - due to CT specifications reported below.
• • History or presence of malignant neoplasm in the last 5 years (except basal cell and squamous cell skin cancer and carcinoma in situ).
• • 14. History of diabetic ketoacidosis.
• • 15. Participation in another clinical trial investigating a drug.
• • 16. Participation in a clinical trial specifically evaluating stent(s) will be allowed.
• • 17. Uncontrolled systemic arterial hypertension with multiple antihypertensive agents.
• • 18. Any disorder that, in the opinion of the researcher, may compromise patient safety or protocol compliance.