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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03322332
Other study ID # 741
Secondary ID
Status Recruiting
Phase N/A
First received October 23, 2017
Last updated October 23, 2017
Start date October 23, 2017
Est. completion date January 22, 2018

Study information

Verified date October 2017
Source University Hospital, Ioannina
Contact Eustratios Apostolakis, Professor
Phone 0030 2651099679
Email stratisapostolakis@yahoo.gr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date January 22, 2018
Est. primary completion date January 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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


Locations

Country Name City State
Greece University Hospital of Ioannina Ioánnina

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Ioannina

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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