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Status unknownNCT03322332Updated Oct 26, 2017

Adipokines of Epicardial Adipose Tissue and Atherosclerosis of Coronary Arteries

An observational study in Coronary Atherosclerosis and Adipokines, sponsored by University Hospital, Ioannina. Status unknown at 1 site in Greece. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-26.

Sponsored by University Hospital, Ioannina · Observational

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
160
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronary Atherosclerosis
  • Adipokines

Keywords

  • adiponectin
  • omentin-1
  • resistin
  • RBP4
  • epicardial fat
  • Coronary artery disease
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Individuals undergoing cardiac surgery will be recruited in this study.

Inclusion criteria

  1. Individuals undergoing cardiac surgery

Exclusion criteria

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
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
160 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

05

What researchers measure

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)

    Time frame: Baseline measurement

Secondary outcomes

  1. 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: 1. NonDM-0 vs DM-0 2. NonDM-L vs DM-L 3. NonDM-R vs DM-R 4. NonDM-LR vs DM-LR

    Time frame: Baseline measurement

06

Study locations

1 of 1 sites recruiting
  • University Hospital of Ioannina
    Ioánnina, Greece
    • Vasiliki Kyrouli · Contact · 0030 2651099519
    Recruiting
07

Registry details

Key details

Study ID
NCT03322332
Lead sponsor
University Hospital, Ioannina
Responsible party
Georgios A. Christou (Cardiologist, Postdoctoral researcher, University Hospital, Ioannina) — Principal investigator
First posted
Oct 26, 2017
Start date
Oct 23, 2017
Primary completion
Jan 15, 2018 (estimated)
Completion
Jan 22, 2018 (estimated)
Last update
Oct 26, 2017

Study contacts

Eustratios Apostolakis, Professor
Contact
stratisapostolakis@yahoo.gr
0030 2651099679
Eustratios Apostolakis, Professor
study director · University Hospital, Ioannina

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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