Effect of Oral Semaglutide on Epicardial and Pericoronary Adipose Tissues in Type 2 Diabetes After Myocardial Infarction
- Conditions
- Diabetic PatientsAcute Myocardial Infarction
- Registration Number
- NCT06557811
- Lead Sponsor
- University of Sao Paulo General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 88
Inclusion Criteria:<br><br>Male or female patient aged 50 years or older at the time of screening, diagnosed with<br>type 2 diabetes and with a previous acute myocardial infarction more than 2 and less than<br>9 months ago, with the following conditions:<br><br> 1. Signed Informed Consent Form.<br><br> 2. BMI = 25 and < 40 kg/m².<br><br> 3. The following glucose-lowering agents are permitted: any insulin, insulin analogs,<br> sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase<br> inhibitors, and SGLT-2 inhibitors (iSGLT2).<br><br> 4. Patients using iSGLT2 will not be excluded because they receive this medication at<br> no cost at InCor with benefits for the treatment of type 2 diabetes. Furthermore,<br> there would be an impact on ethical issues and the control of this prescription in<br> other clinics. Thus, we will list the patients using SGLT2 inhibitors and<br> statistically evaluate the comparison with the group that did not use this<br> medication.<br><br>Exclusion Criteria:<br><br> 1. Patients with type 1 diabetes.<br><br> 2. Type 2 diabetes currently or previously treated (within 90 days prior to screening)<br> with any GLP-1RA and DPP-4 inhibitor.<br><br> 3. Those not properly treated for previously diagnosed hypothyroidism.<br><br> 4. Diagnosed with NYHA class IV heart failure.<br><br> 5. Myocardial infarction more than 9 months after diagnosis.<br><br> 6. Any of the following: myocardial infarction, stroke, or hospitalization for unstable<br> angina or transient ischemic attack within 60 days before screening.<br><br> 7. Any contraindication present in the package insert for the use of GLP1-RA or Oral<br> Semaglutide.<br><br> 8. Desire to become pregnant.<br><br> 9. Previous history of pancreatitis (acute or chronic).<br><br> 10. Family or personal history of multiple endocrine neoplasia type 2 or medullary<br> thyroid carcinoma.<br><br> 11. History of major surgical procedures involving the stomach, potentially affecting<br> the absorption of the test product (e.g., subtotal and total gastrectomy, vertical<br> gastrectomy, gastric bypass surgery).<br><br> 12. Planned and known coronary, carotid, or peripheral arterial revascularization on the<br> day of screening.<br><br> 13. Chronic or intermittent hemodialysis, peritoneal dialysis, or severe renal<br> insufficiency (corresponding to eGFR < 30 mL/min/1.73 m²) - due to CT specifications<br> reported below.<br><br> History or presence of malignant neoplasm in the last 5 years (except basal cell and<br> squamous cell skin cancer and carcinoma in situ).<br><br> 14. History of diabetic ketoacidosis.<br><br> 15. Participation in another clinical trial investigating a drug.<br><br> 16. Participation in a clinical trial specifically evaluating stent(s) will be allowed.<br><br> 17. Uncontrolled systemic arterial hypertension with multiple antihypertensive agents.<br><br> 18. Any disorder that, in the opinion of the researcher, may compromise patient safety<br> or protocol compliance.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measurement of pericardial adipose tissue at 180 days;Measurement of the fat attenuation index at 180 days;Measurement of the perivascular adipose tissue attenuation index at 180 days
- Secondary Outcome Measures
Name Time Method