[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558952":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":54,"collaborators":34,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":34,"enrollmentInfo":67,"targetDuration":34,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":81,"whyStopped":34,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Semaglutide","2 groups: This group will receive semaglutide",[12],"Drug: Semaglutide",{"label":14,"type":6,"description":15,"interventionNames":16},"Placebo","2 groups: This group will receive placebo (control population).",[12],[18],{"type":19,"name":9,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","After 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.",[14,9],[23],"Rybelsus",[25],{"name":26,"affiliation":27,"role":28},"Carlos V Serrano Junior, MD PHD","InCOR- University of Sao Paulo","PRINCIPAL_INVESTIGATOR",[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"ARO InCOR HC FMUSP","CONTACT","551126615795",null,"aro@incor.usp.br",{"name":37,"role":32,"phone":33,"phoneExt":34,"email":35},"InCor HC FMUSP",[39],{"facility":40,"status":34,"city":41,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"ARO (Academic Research Organization)","São Paulo","05403-900","Brazil","BR",{"type":46,"coordinates":47},"Point",[48,49],-46.63611,-23.5475,{"lat":49,"lon":48},[52],{"name":53,"role":32,"phone":33,"phoneExt":34,"email":35},"ARO InCor",{"type":28,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Carlos Vicente Serrano Jr","Professor Doctor","100558952","phase-4-effect-of-oral-semaglutide-on-epicardial-and-pericoronary-adipose-tissues-in-type-2-diabetes-after-myocardial-infarction-100558952",false,"NCT06557811","Effect of Oral Semaglutide on Epicardial and Pericoronary Adipose Tissues in Type 2 Diabetes After Myocardial Infarction","Effect of Oral Semaglutide on Epicardial and Pericoronary Adipose Tissues in Type 2 Diabetes After Myocardial Infarction: a Randomized and Double-blind Clinical Trial","SemaFatCard","Inclusion Criteria:\n\nMale 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:\n\n1. Signed Informed Consent Form.\n2. BMI ≥ 25 and \\\u003C 40 kg\u002Fm².\n3. The following glucose-lowering agents are permitted: any insulin, insulin analogs, sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, and SGLT-2 inhibitors (iSGLT2).\n4. 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.\n\nExclusion Criteria:\n\n1. Patients with type 1 diabetes.\n2. Type 2 diabetes currently or previously treated (within 90 days prior to screening) with any GLP-1RA and DPP-4 inhibitor.\n3. Those not properly treated for previously diagnosed hypothyroidism.\n4. Diagnosed with NYHA class IV heart failure.\n5. Myocardial infarction more than 9 months after diagnosis.\n6. Any of the following: myocardial infarction, stroke, or hospitalization for unstable angina or transient ischemic attack within 60 days before screening.\n7. Any contraindication present in the package insert for the use of GLP1-RA or Oral Semaglutide.\n8. Desire to become pregnant.\n9. Previous history of pancreatitis (acute or chronic).\n10. Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.\n11. 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).\n12. Planned and known coronary, carotid, or peripheral arterial revascularization on the day of screening.\n13. Chronic or intermittent hemodialysis, peritoneal dialysis, or severe renal insufficiency (corresponding to eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²) - due to CT specifications reported below.\n\n    History or presence of malignant neoplasm in the last 5 years (except basal cell and squamous cell skin cancer and carcinoma in situ).\n14. History of diabetic ketoacidosis.\n15. Participation in another clinical trial investigating a drug.\n16. Participation in a clinical trial specifically evaluating stent(s) will be allowed.\n17. Uncontrolled systemic arterial hypertension with multiple antihypertensive agents.\n18. Any disorder that, in the opinion of the researcher, may compromise patient safety or protocol compliance.","ALL","50 Years",{"count":68,"type":69},88,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","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.\n\nThe primary objective is to investigate the ability of oral semaglutide to reduce pericardial and perivascular fat in type 2 diabetics after myocardial infarction.\n\nThe primary outcome will be composed of three measures:\n\nMeasurement 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.\n\nTo 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.\n\nOral semaglutide may reduce pericardial and\u002For perivascular fat in diabetics after acute myocardial infarction.",[75,76],"Diabetic Patients","Acute Myocardial Infarction",[78,79,80],"Diabetes","Acute myocardial infarction","Oral Semaglutide","NOT_YET_RECRUITING","2024-08-22",{"date":84,"type":85},"2024-08-26","ACTUAL",{"date":87,"type":69},"2024-09-01",{"date":89,"type":69},"2026-09-01",{"name":5,"class":6},1]