Effects of Agonists of Glucagon Like Peptide - 1 Receptors (GLP-1R) on Arterial Stiffness, Endothelial Glycocalyx and Coronary Flow Reserve in Patients With Coronary Artery Disease and Patients With Diabetes Mellitus

Summary

Arterial stiffness is associated with increased risk for cardiovascular disease. Moreover, the integrity of endothelial glycocalyx plays a vital role in vascular permeability, inflammation and elasticity. Agonists of Glucagon like peptide - 1 receptors (GLP-1R) used in the treatment of type 2 diabetes mellitus (T2DM). This category includes exenatide and liraglutide. These drugs lower glucose levels by inhibiting the secretion of glucagon, promoting the release of insulin in response to hyperglycemia, slowing gastric emptying, and augmenting satiety. Clinical studies have shown that GLP-1R agonists have beneficial effects on cardiovascular function in both diabetic patients and healthy subjects. The purpose of this study is to investigate in patients with T2DM without coronary artery disease (CAD), patients with T2DM and CAD and obese patients with abnormal oral glucose tolerance test (OGTT), changes in arterial stiffness, endothelial glycocalyx thickness and coronary reserve flow (CFR) after treatment with metformin or agonist GLP-1R.

Conditions

• Type 2 Diabetes Mellitus
• Coronary Artery Disease

Interventions

DRUG

Liraglutide

Stimulation of Glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8mg once daily as a subcutaneous injection

DRUG

Metformin

Antidiabetic drug-biguanide class (Glucophage) 1000mg twice daily per os

Sponsors & Collaborators

• University of Athens

  lead OTHER

Principal Investigators

• Ignatios Ikonomidis, MD · 2nd Cardiology Department, University of Athens, Greece

• George Pavlidis, MD · 2nd Cardiology Department, University of Athens, Greece

• Vaia Lambadiari, MD · 2nd Department of Internal Medicine, University of Athens, Greece

• Fotini Kousathana, MD · 2nd Department of Internal Medicine, University of Athens, Greece

• George Dimitriadis, MD · 2nd Department of Internal Medicine, University of Athens, Greece

• John Lekakis, MD · 2nd Cardiology Department, University of Athens, Greece

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-11-30

Primary Completion

2017-06-30

Completion

2017-12-31

Countries

• Greece

Study Locations