Status:
NOT_YET_RECRUITING
Effect of Oral Semaglutide on Epicardial and Pericoronary Adipose Tissues in Type 2 Diabetes After Myocardial Infarction
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Diabetic Patients
Acute Myocardial Infarction
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to investigate the ability of oral semaglutide to reduce pericardial and perivascular fat as well as coronary plaque in type 2 diabetic patients after acute myocardi...
Detailed Description
TITLE: Effect of Oral Semaglutide on Epicardial and Pericoronary Adipose Tissues in Type 2 Diabetic Patients After Myocardial Infarction. OBJECTIVE: This randomized, placebo-controlled study primaril...
Eligibility Criteria
Inclusion
- 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:
- Signed Informed Consent Form.
- BMI ≥ 25 and \< 40 kg/m².
- The following glucose-lowering agents are permitted: any insulin, insulin analogs, sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, and SGLT-2 inhibitors (iSGLT2).
- 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
- Patients with type 1 diabetes.
- Type 2 diabetes currently or previously treated (within 90 days prior to screening) with any GLP-1RA and DPP-4 inhibitor.
- Those not properly treated for previously diagnosed hypothyroidism.
- Diagnosed with NYHA class IV heart failure.
- Myocardial infarction more than 9 months after diagnosis.
- Any of the following: myocardial infarction, stroke, or hospitalization for unstable angina or transient ischemic attack within 60 days before screening.
- Any contraindication present in the package insert for the use of GLP1-RA or Oral Semaglutide.
- Desire to become pregnant.
- Previous history of pancreatitis (acute or chronic).
- Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- 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).
- Planned and known coronary, carotid, or peripheral arterial revascularization on the day of screening.
- 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).
- History of diabetic ketoacidosis.
- Participation in another clinical trial investigating a drug.
- Participation in a clinical trial specifically evaluating stent(s) will be allowed.
- Uncontrolled systemic arterial hypertension with multiple antihypertensive agents.
- Any disorder that, in the opinion of the researcher, may compromise patient safety or protocol compliance.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT06557811
Start Date
September 1 2024
End Date
September 1 2026
Last Update
August 26 2024
Active Locations (1)
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1
ARO (Academic Research Organization)
São Paulo, São Paulo, Brazil, 05403-900