Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06557811
PHASE4

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

Sponsor: University of Sao Paulo General Hospital

View on ClinicalTrials.gov

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.

Official title: Effect of Oral Semaglutide on Epicardial and Pericoronary Adipose Tissues in Type 2 Diabetes After Myocardial Infarction: a Randomized and Double-blind Clinical Trial

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2024-09-01

Completion Date

2026-09-01

Last Updated

2024-08-26

Healthy Volunteers

No

Interventions

DRUG

Semaglutide

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.

Locations (1)

ARO (Academic Research Organization)

São Paulo, São Paulo, Brazil