Epicardial Fat and Clinical Outcomes After Coronary Artery Bypass Grafting in Diabetics vs. Non Diabetics

April 22, 2026 updated by: Celestino Sardu, University of Campania Luigi Vanvitelli

Epicardial Fat Evaluation to Predict Clinical Outcomes in Patients Affected by Coronary Artery Disease and Treated by Coronary Artery Bypass Grafting: Diabetic vs. Non Diabetic Patients, and Incretin Therapy Effect; The EPI.FAT.IN Study

Cardiovascular disease (CVD) is a group of diseases including both the heart and blood vessels, thereby including coronary heart disease (CHD). To date, diabetics have a higher incidence and prevalence of multivessels CHD. Treatments in multivessels CHD in diabetics include full medical anti ischemic therapy, and revascularization therapy (Percutaneous coronary intervention (PCI) and/or Coronary artery bypass grafting (CABG)). Randomized trials comparing multivessel PCI to CABG have consistently demonstrated the superiority of CABG in reducing mortality, myocardial infarctions and need for repeat revascularizations. After the CABG treatment, diabetics vs. non-diabetics evidenced a worse prognosis, and an increased mortality. Numerous molecular, epigenetics (as microRNAs), and other metabolic risk factors may condition the worse prognosis in diabetics vs. non diabetics after CABG. In this context, an increased epicardial fat tissue thickness may be independently associated with the prevalence of diabetes, and diabetics have an higher epicardial fat tissue thickness, volumetry, and enhanced metabolism. Therefore, after CABG, lifestyle and medical improvements may lead to the reduction of epicardial fat thickness, extension, and metabolism in both non-diabetics, and diabetics, ameliorating the prognosis. At moment, epicardial tissue function in diabetics is not well investigated in literature, and no data has been reported about new hypoglycemic drugs, and its pleiotropic effects on diabetics after CABG. Indeed, our study hypothesis was that, epicardial fat tissue dimension, and metabolic activity may be related to a different expression of inflammatory, oxidative, and apoptotics molecules, and epigenetic effectors in diabetics vs. non-diabetics. Secondary, these effectors, and epicardial tissue dimension and activity, may be controlled, after CABG, by incretin treatment in diabetics. Therefore, incretin therapy may be associated to the reduction in epicardial fat tissue thickness, and extension, with down regulation of different inflammatory, oxidative and apoptotics molecules, and epigenetic effectors involved in epicardial fat metabolism. Moreover, in this study authors will evaluate in diabetics vs. non diabetics, and in diabetic incretin-users vs. never.-incretin-users, all cause mortality, cardiac mortality, and Major adverse cardiac events (MACE) after CABG in diabetics vs. non diabetics, and diabetic incretin-users (6 months of incretin therapy) vs. diabetic never-incretin-users. Authors will correlate these clinical endpoints to the study of the epicardial fat anatomy and metabolism before and after CABG, and to circulating inflammatory and pro-apoptotic markers, epigenetic effectors, and stem cells in diabetics vs. non diabetics, and diabetic incretin-users (6 months of incretin therapy) vs. diabetic never-incretin-users.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cardiovascular disease (CVD) is a group of diseases that include both the heart and blood vessels, thereby including coronary heart disease (CHD) and coronary artery disease (CAD), and acute coronary syndrome (ACS) among several other conditions. CHD causes about one-third of all deaths in people older than 35 years. Diabetes Mellitus (DM) is independently associated with a 2 to 4-fold increased mortality risk from heart disease, and with an increased mortality after myocardial infarction (MI), and worse overall prognosis with CAD. To date, DM patients have a higher incidence and prevalence of multivessels CAD. Treatments in multivessels CAD diabetics include full medical anti ischemic therapy (antiplatelets drugs, beta blockers, anti-remodelling drugs, anti-diabetic drugs etc), and revascularization therapy (Percutaneous coronary intervention (PCI) and/or Coronary artery bypass grafting (CABG)). Randomized trials comparing multivessel PCI to coronary artery bypass grafting (CABG) have consistently demonstrated the superiority of CABG in reducing mortality, myocardial infarctions and need for repeat revascularizations. After the CABG treatment, diabetics vs. non-diabetics evidenced a worse prognosis, and an increased mortality at follow up. The causes of the worse prognosis after CABG in diabetics are not well known, and under-investigated. Authors may speculate that, numerous molecular, epigenetics (as microRNAs), and other metabolic risk factors may condition the worse prognosis in diabetics vs. non diabetics after CABG. In this context, recently authors investigated the impact of epicardial adipose fat tissue dimension and metabolism on cardiovascular clinical outcomes. Intriguingly, an increased epicardial fat tissue thickness may be independently associated with the prevalence of diabetes. Consequently, diabetics have an higher epicardial fat tissue thickness, volumetry, and enhanced metabolism. Therefore, authors may speculate that, epicardial fat tissue may work as a metabolically active tissue, by a direct action on the heart, and by a cross talking with various metabolic derangements in the body leading to insulin resistance, atherosclerosis, metabolic syndrome, and cardiovascular disease. Moreover, after CABG, lifestyle and medical improvements may lead to the reduction of epicardial fat thickness, extension, and metabolism in both non-diabetics, and diabetics. Therefore, a part of the lifestyle modifications, also the hypoglycemic drugs therapy may lead to modification of epicardial fat tissue. However, authors may speculate that, the epicardial fat tissue thickness, volumetry, and metabolism, probably due to inflammatory and oxidative molecules activity, and epigenetic and anti-apoptotic pathways (as Sirtuins expression), may lead to a balance between epicardial fat tissue growth and/or reduction, and then all these pathways may be consequently involved in the prognosis of diabetics vs. non diabetics patients after CABG. At moment, all these pathways remain not well investigated in literature, and no data has been reported about new hypoglycemic drugs, and its pleiotropic effects on diabetics after CABG. Indeed, authors study hypothesis was that, epicardial fat tissue dimension, and metabolic activity may be related to a different expression of inflammatory, oxidative, and apoptotics molecules, and epigenetic effectors in diabetics vs. non-diabetics. Secondary, these effectors, and epicardial tissue dimension and activity, may be controlled, after CABG, by incretin treatment in diabetics. Moreover, higher epicardial fat tissue thickness, and tissue extension, may be associated with worse prognosis in diabetics after CABG. Secondary, in diabetics with better response to CABG, there may be a more important reduction of epicardial fat tissue tickness at follow up. This effect may be due to the control of different inflammatory, oxidative, and apoptotics molecules, and epigenetic effectors in diabetics undergoing CABG, and related to better clinical outcomes. Authors study hypothesis, is that incretin therapy may be associated to the reduction in epicardial fat tissue thickness, and extension. This effect in diabetics incretin-users vs. never-incretin-users may be due to the down regulation of different inflammatory, oxidative and apoptotics molecules, and epigenetic effectors involved in epicardial fat metabolism. Moreover, in this study authors will evaluate in diabetics vs. non diabetics, and in diabetic incretin-users vs. never.-incretin-users, all cause mortality, cardiac mortality, and Major adverse cardiac events (MACE) after CABG in diabetics vs. non diabetics, and diabetic incretin-users (6 months of incretin therapy) vs. diabetic never-incretin-users. Authors will correlate these clinical endpoints to the study of the epicardial fat anatomy and metabolism before and after CABG, and to the study of circulating inflammatory and pro-apoptotic markers, epigenetic effectors, and stem cells in diabetics vs. non diabetics, and diabetic incretin-users (6 months of incretin therapy) vs. diabetic never-incretin-users. A part of this, authors may speculate to recognize new cellular, molecular, and inflammatory processes, and epigenetic effectors epicardial fat derived related to these effects on clinical outcomes, and then used as specifical targets to improve clinical outcomes after CABG in diabetics.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Locations

  • Italy
    • Italy
      • Naples, Italy, Italy, 80128
        • Raffaele Marfella

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • patients aged >18, <75, left ventricle ejection fraction (LVEF) >50%, multivessel coronary disease detected by coronarography, indication to receive a CABG, stable CAD. All diabetics and non diabetics.

Exclusion Criteria:

  • acute myocardial infarction, heart failure, neoplastic disease, chronic diseases that may affect the inflammatory profile both systemic and epicardial (cancer, chronic intestinal inflammation, hepatitis, AIDS); life expectancy < 6 months, previous CABG and/or other open heart surgery intervention, acute coronary syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: diabetics incretin-users (arm 1)
epicardial tissue biopsy, and than treated by incretin therapy plus standard anti ischemic therapy.
Drug: Incretins
after CABG, and epicardial tissue biopsy, patients will receive incretin therapy.
Placebo Comparator: diabetics never-incretin-users (arm 2)
epicardial tissue biopsy, and than treated by standard hypoglycemic drug therapy plus standard anti ischemic therapy.
Drug: Incretins
after CABG, and epicardial tissue biopsy, patients will receive incretin therapy.
No Intervention: non diabetics (arm 3)
non diabetics, treated by coronary artery bypass grafting (CABG), receiving epicardial tissue biopsy, and than treated by standard anti ischemic therapy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: 12 months
Authors will evaluate all cause of mortality in in diabetics vs. non diabetics, and in diabetics incretin-users vs. never-incretin-users by hospital discharge schedules, deaths registry, and during follow up visits.
12 months
cardiac mortality
Time Frame: 12 months
Authors will evaluate cardiac mortality in in diabetics vs. non diabetics, and in diabetics incretin-users vs. never-incretin-users by hospital discharge schedules, deaths registry, and during follow up visits.
12 months
Major adverse cardiac events (MACE)
Time Frame: 12 months
Authors will evaluate MACE in in diabetics vs. non diabetics, and in diabetics incretin-users vs. never-incretin-users by hospital discharge schedules, hospitalization schedules, and during follow up visits.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
molecular markers (Sirtuin 1, 6, etc) to predict study endpoints
Time Frame: 12 months
Authors will evaluate sirtuin1, 6 etc in in diabetics vs. non diabetics, and in diabetics incretin-users vs. never-incretin-users by blood samples during hospitalization, and during follow up visits.
12 months
serum microRNAs and epicardial fat microRNAs,
Time Frame: 12 months
Authors will evaluate serum microRNAs and epicardial fat microRNAs in diabetics vs. non diabetics, and in diabetics incretin-users vs. never-incretin-users by blood samples during hospitalization, and during follow up visits.clinical outcomes.
12 months
stem cells isolated in epicardial fat.
Time Frame: 12 months
Authors will evaluate epicardial fat derived stem cells in diabetics vs. non diabetics, and in diabetics incretin-users vs. never-incretin-users by blood samples during hospitalization, and during follow up visits. Epicardial derived stem cells will be evaluated during CABG.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Campania Luigi Vanvitelli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 28.11.2017.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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