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

What Was Tested

This registered phase 4 trial tested Semaglutide.

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.

It had two arms (groups): Semaglutide (other) and Placebo (other).

2 groups: This group will receive semaglutide.

2 groups: This group will receive placebo (control population).

The registry classes the interventions as drug.

More on the Plan

TITLE: Effect of Oral Semaglutide on Epicardial and Pericoronary Adipose Tissues in Type 2 Diabetic Patients After Myocardial Infarction.

MATERIAL AND METHODS: Equipment: Cardiac Computed Tomography (CCT) and Echocardiography: A standard CTA protocol using a 320 detector-row scanner (Aquillion ONE, Canon Medical Systems, Ottawa, Japan), including coronary calcium score (CCS) and CTA, will be performed.

The CTA parameters are as follows: collimation 0.5 mm, rotation time 400 ms, tube voltage and current 100-120 kV and 250-550 mA, adjusted to body mass index.

STUDY DESIGN: Prospective, placebo-controlled, double-blind, single-center randomized study with 4 phases: First phase: Screening of chronic patients who had AMI with T2D for more than 1 month and less than 6 months in the InCor database, according to inclusion criteria.

Who Took Part

The registry lists 88 planned participants were the target.

It was open to people of any sex aged from 50 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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).

The full record lists 4 inclusion and 18 exclusion criteria; among the exclusions: patients with type 1 diabetes; 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.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-09-01 with completion listed for 2024-09-01.

It ran at 1 site in Brazil.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Measurement of pericardial adipose tissue at 180 days (time frame: 180 days). Measurement of the fat attenuation index at 180 days (time frame: 180 days). Measurement of the perivascular adipose tissue attenuation index at 180 days (time frame: 180 days).

It also tracked 23 secondary outcomes, for example Determination of metabolic marker levels fasting blood glucose, Determination of metabolic marker levels HbA1c, Determination of metabolic marker levels Insulin, Determination of metabolic marker levels HOMA-IR, Determination of metabolic marker levels total cholesterol and fractions and Determination of metabolic marker levels uric acid.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 88 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.