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 myocardial infarction. Patients of both sexes, aged 50 years or older, diagnosed with type 2 diabetes and with a previous acute myocardial infarction between more than 2 and less than 9 months ago, will be included.
The primary objective is to investigate the ability of oral semaglutide to reduce pericardial and perivascular fat in type 2 diabetics after myocardial infarction.
The primary outcome will be composed of three measures:
Measurement of pericardial adipose tissue at 180 days; Measurement of the perivascular adipose tissue attenuation index at 180 days; Measurement of the fat attenuation index at 180 days.
To assess the degree of epicardial and perivascular fat attenuation, coronary artery computed tomography will be performed, and to evaluate the left ventricular ejection fraction, transthoracic echocardiography will be conducted.
Oral semaglutide may reduce pericardial and/or perivascular fat in diabetics after acute myocardial infarction.
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.
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.
Parallel
Semaglutide
DrugAfter randomization, each patient will receive four blisters of 3 mg tablets (semaglutide or placebo) and four blisters of 7 mg tablets (semaglutide or placebo), to be taken before breakfast. After 60 days, the patient will receive a 14 mg dose (a total of 16 blisters with 7 tablets each). The possibility of maintaining the 14 mg dose of the study drug or reducing it to 7 mg will be evaluated depending on side effects and tolerability.
Measurement of pericardial adipose tissue at 180 days
Measurement of pericardial adipose tissue (cm³)
Measurement of the fat attenuation index at 180 days
Measurement of the fat attenuation index (Hounsfield units (HU))
Measurement of the perivascular adipose tissue attenuation index at 180 days
Measurement of the perivascular adipose tissue attenuation index (Hounsfield units (HU))
Determination of metabolic marker levels fasting blood glucose
Determination of metabolic marker level: fasting blood glucose (mg/dL)
Determination of metabolic marker levels HbA1c
Determination of metabolic marker level: HbA1c (%)
Determination of metabolic marker levels Insulin
Determination of metabolic marker level: Insulin (µU/mL)
Determination of metabolic marker levels HOMA-IR
Determination of metabolic marker level:HOMA-IR
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