Adipokines of Epicardial Adipose Tissue and Atherosclerosis of Coronary Arteries

The Role of Adipokines Secreted by Epicardial Adipose Tissue in the Atherosclerosis of Coronary Arteries

The aim of the study is to investigate whether the expression and production of adipokines secreted by the epicardial adipose tissue correlate with the degree of coronary atherosclerosis.

Study Overview

• Status: Unknown
• Conditions: Coronary Atherosclerosis; Adipokines

Detailed Description

The aim of the study is to investigate whether the expression and production of four adipokines [adiponectin, omenin-1, resistin and retinol binding protein-4 (RBP4)] secreted by the epicardial adipose tissue correlate with the degree of coronary atherosclerosis. Specifically, this study aims to investigate whether the expression and production of these adipokines is different between two sites of the heart, that are perfused by coronary arteries with different degrees of stenosis.

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

Study Locations

• Greece
  • Ioánnina, Greece
    • Recruiting
    • University Hospital of Ioannina
    • Contact: Vasiliki Kyrouli; Phone Number: 0030 2651099519

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Individuals undergoing cardiac surgery will be recruited in this study.

Description

Inclusion Criteria:

1) Individuals undergoing cardiac surgery

Exclusion Criteria:

• Age < 18 years
• HbA1c > 7.0%
• Any change of antidiabetic medication the previous 3 months before the surgery
• GFR < 60 mL/min/1.73 m2
• Liver disease
• Cancer
• Non-treated hyperthyroidism or hypothyroidism
• Autoimmune disease
• Infection
• Any change in body weight at least 5% the previous 3 months before surgery
• Significant dehydration.
• Taking any of the following drugs the previous 3 months before surgery: hormones, antiobesity drugs

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort
NonDM-0; Nondiabetics without significant stenoses (> 50%) in the coronary arteries
NonDM-L; Nondiabetics with significant stenosis in the left anterior descending (LAD) coronary artery or in the Left main (LM) coronary artery, but without significant stenosis in the right coronary artery (RCA)
NonDM-R; Nondiabetics without significant stenosis in the LAD and in the LM, but with significant stenosis in the RCA
NonDM-LR; Nondiabetics with significant stenosis in the LAD or in the LM and with significant stenosis in the RCA
DM-0; Patients with type 2 diabetes mellitus (T2DM) without significant stenoses in the coronary arteries
DM-L; T2DM patients with significant stenosis in the LAD or in the LM, but without significant stenosis in RCA
DM-R; T2DM patients without significant stenosis in the LAD and in the LM, but with significant stenosis in the RCA
DM-LR; T2DM patients with significant stenosis in the LAD or in the LM and with significant stenosis in the RCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between coronary artery disease and epicardial adipokines	Comparison of the mRNA and protein production of four adipokines [adiponectin, omentin-1, resistin, retinol binding protein-4(RBP4)] from the epicardial adipose tissue between the territories that are supplied by LAD and RCA. This comparison will be performed in the following clusters of groups: Cluster 1: NonDM-0 and DM-0 (comparison between territories that are supplied by non-stenosed coronary arteries); Cluster 2: NonDM-LR and DM-LR (comparison between territories that are supplied by stenosed coronary arteries); Cluster 3: NonDM-L, NonDM-R, DM-L and DM-R (comparison between a territory that is supplied by stenosed coronary artery and another territory that is supplied by non-stenosed coronary artery)	Baseline measurement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of diabetes on epicardial adipokines	Comparison of the mRNA and protein production of four adipokines (adiponectin, omentin-1, resistin, RBP4) from the epicardial adipose tissue of the territory that is supplied by LAD or RCA between the following groups: NonDM-0 vs DM-0; NonDM-L vs DM-L; NonDM-R vs DM-R; NonDM-LR vs DM-LR	Baseline measurement

Collaborators and Investigators

• Sponsor: University Hospital, Ioannina
• Investigators: Study Director: Eustratios Apostolakis, Professor, University Hospital, Ioannina

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2017
• Primary Completion (Anticipated): January 15, 2018
• Study Completion (Anticipated): January 22, 2018

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (Actual): October 26, 2017

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 23, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Coronary artery disease; adiponectin; epicardial fat; resistin; omentin-1; RBP4
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis
• Other Study ID Numbers: 741

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No