Effect of Oral Semaglutide on Epicardial and Pericoronary Adipose Tissues in Type 2 Diabetes Afte… (NCT06557811) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Effect of Oral Semaglutide on Epicardial and Pericoronary Adipose Tissues in Type 2 Diabetes After Myocardial Infarction
Brazil88 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. Patients with type 1 diabetes.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurement of pericardial adipose tissue at 180 days
Timeframe: 180 days
2
Measurement of the fat attenuation index at 180 days
Timeframe: 180 days
3
Measurement of the perivascular adipose tissue attenuation index at 180 days
. 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.