Adipokines of Epicardial Adipose Tissue and Atherosclerosis of Coronary Arteries

• Conditions: Coronary Atherosclerosis; Adipokines

• Registration Number: NCT03322332
• Lead Sponsor: University Hospital, Ioannina

Brief Summary

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.

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 Timeline

• Status Verified: 2017-10
• Study Start: 2017-10-23
• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-23
• Last Update Submitted: 2017-10-23
• Study First Posted: 2017-10-26
• Last Update Posted: 2017-10-26
• Primary Completion: 2018-01-15
• Study Completion: 2018-01-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association between coronary artery disease and epicardial adipokines	Baseline measurement	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: 1. Cluster 1: NonDM-0 and DM-0 (comparison between territories that are supplied by non-stenosed coronary arteries); 2. Cluster 2: NonDM-LR and DM-LR (comparison between territories that are supplied by stenosed coronary arteries); 3. 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)

Secondary Outcome Measures

Name	Time	Method
Impact of diabetes on epicardial adipokines	Baseline measurement	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: 1. NonDM-0 vs DM-0; 2. NonDM-L vs DM-L; 3. NonDM-R vs DM-R; 4. NonDM-LR vs DM-LR

Trial Locations

Locations (1)

University Hospital of Ioannina; 🇬🇷 Ioánnina, Greece