Effect of Oral Semaglutide on Epicardial and Pericoronary Adipose Tissues in Type 2 Diabetes After Myocardial Infarction

Sponsor
University of Sao Paulo General Hospital
Study ID
NCT06557811
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Acute Myocardial Infarction
  • Diabetic Patients

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — 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.

Study Details

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.

Key Dates

Start date
Sep 1, 2024
Status verified
Aug 2024
Primary completion
Sep 1, 2024
Completion
Sep 1, 2026

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Other: Semaglutide
    2 groups: This group will receive semaglutide
  • Other: Placebo
    2 groups: This group will receive placebo (control population).

Primary Outcome Measure

Measurement of pericardial adipose tissue at 180 days [ Time Frame: 180 days ]

Central Contacts

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