Adipokines of Epicardial Adipose Tissue and Atherosclerosis of Coronary Arteries

NCT03322332 | Unknown

• 1 other identifier: 741
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Atherosclerosis; Adipokines

Keywords

adiponectin; omentin-1; resistin; RBP4; epicardial fat; Coronary artery disease

Outcome Measures

Primary Outcomes (1)

• 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: 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)

  Baseline measurement

Secondary Outcomes (1)

• Impact of diabetes on epicardial adipokines

  Baseline measurement

Study Arms (8)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals undergoing cardiac surgery will be recruited in this study.

You may qualify if:

• \) Individuals undergoing cardiac surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ioannina: lead

Study Sites (1)

University Hospital of Ioannina

Ioannina, Greece

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Eustratios Apostolakis, Professor

  University Hospital, Ioannina

  STUDY DIRECTOR

Central Study Contacts

Eustratios Apostolakis, Professor

CONTACT

0030 2651099679; stratisapostolakis@yahoo.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist, Postdoctoral researcher

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: October 26, 2017
• Study Start: October 23, 2017
• Primary Completion: January 15, 2018
• Study Completion: January 22, 2018
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

GR (1)