Effect of Oral Semaglutide on Epicardial and Pericoronary Adipose Tissues in Type 2 Diabetes After Myocardial Infarction
NCT Number: NCT06557811
Acronym: SemaFatCard
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Diabetic Patients|Acute Myocardial Infarction
Interventions: DRUG: Semaglutide
Sponsor: University of Sao Paulo General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 88
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2026-09-01
Locations: ARO (Academic Research Organization), São Paulo, SP, 05403-900, Brazil

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 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.

Primary Outcome Measures: Measurement of pericardial adipose tissue at 180 days, Measurement of pericardial adipose tissue (cm³), 180 days|Measurement of the fat attenuation index at 180 days, Measurement of the fat attenuation index (Hounsfield units (HU)), 180 days|Measurement of the perivascular adipose tissue attenuation index at 180 days, Measurement of the perivascular adipose tissue attenuation index (Hounsfield units (HU)), 180 days
Secondary Outcome Measures: Determination of metabolic marker levels fasting blood glucose, Determination of metabolic marker level: fasting blood glucose (mg/dL), 180 days|Determination of metabolic marker levels HbA1c, Determination of metabolic marker level: HbA1c (%), 180 days|Determination of metabolic marker levels Insulin, Determination of metabolic marker level: Insulin (µU/mL), 180 days|Determination of metabolic marker levels HOMA-IR, Determination of metabolic marker level:HOMA-IR, 180 days|Determination of metabolic marker levels total cholesterol and fractions, Determination of metabolic marker levels:total cholesterol and fractions (mg/dL), 180 days|Determination of metabolic marker levels uric acid, Determination of metabolic marker levels:uric acid (mg/dL), 180 days|Determination of metabolic marker levels TSH, Determination of metabolic marker levels:TSH (µUI/mL), 180 days|Determination of metabolic marker levels free T4, Determination of metabolic marker levels: free T4 (ng/dL), 180 days|Determination of complete blood count with platelet count, Determination of complete blood count: Hemoglobin (g/dL), 180 days|Determination of complete blood count, Determination of complete blood count: Hematocrit (%), 180 days|Determination of platelet count, Determination of platelet count (x10\^3/µL), 180 days|Determination of cardiac marker levels Troponin I, Measure of cardiac marker level: Troponin I (ng/mL), 180 days|Determination of cardiac marker levels CK-MB, Measure of cardiac marker level: CK-MB (ng/mL), 180 days|Determination of cardiac marker levels C-Reactive Protein, Measure of cardiac marker level: C-Reactive Protein (mg/L), 180 days|Determination of cardiac marker levels Interleukin 6, Measure of cardiac marker level:Interleukin 6 (pg/mL), 180 days|Determination of cardiac marker levels NT-proBNP, Measure of cardiac marker level: NT-proBNP (pg/mL), 180 days|Determination of anthropometric measurements body mass index, Determination of anthropometric measurement: body mass index (kg/m2), 180 days|Determination of anthropometric measurements Neck Circumference, Determination of anthropometric measurement: Neck Circumference (cm), 180 days|Determination of anthropometric measurements Body Weight, Determination of anthropometric measurement: Body Weight (kg), 180 days|Determination of anthropometric measurements Abdominal Waist, Determination of anthropometric measurement: Abdominal Waist (cm), 180 days|Determination of anthropometric measurements Waist-to-Height Ratio, Determination of anthropometric measurement:Waist-to-Height Ratio, 180 days|Determination of anthropometric measurements Blood Pressure, Determination of anthropometric measurement: Blood Pressure (mmHg), 180 days|Determination of anthropometric measurements Heart Rate, Determination of anthropometric measurement:Heart Rate (bpm), 180 days