Ignite Creation Date:
2024-05-06 @ 9:34 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03010683
Status:
COMPLETED
Last Update Posted:
2021-03-05
First Post:
2016-12-22
Brief Title:
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
Sponsor:
University of Athens
Organization:
University of Athens
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
The investigators will study three groups matched for age and sex 30 patients with type 2 diabetes mellitus T2DM without coronary artery disease CAD 30 patients with T2DM and CAD and 30 obese patients BMI 30 Kgm² with abnormal oral glucose tolerance test OGTT It will be a randomized study with metformin or GLP-1R agonist treatment for 1 year All subjects will receive for 1 year a GLP-1R agonist or b metformin At 0 3 6 and 12 months where 0 is the starting point of treatment blood samples will be collected
At 0 3 6 and 12 months the investigators will measure
1 Carotid-femoral pulse wave velocity PWV msec using tonometry by Complior SP ALAM and augmentation index AI by the method of arteriography Arteriograph TensioMed
2 Perfused boundary region PBR micrometers of the sublingual arterial microvessels ranged from 5-25 micrometers using Sideview Darkfield imaging Microscan Glycocheck Increased PBR is considered an accurate non invasive index of reduced endothelial glucocalyx thickness
3 Coronary flow reserve CFR in the left anterior descending artery after infusion of adenosine using Doppler echocardiography
4 Determination of the following parameters in blood glucose insulin free fatty acids triglycerides glycerol C reactive protein CRP transforming growth factor-b TGF-b Lipoprotein-Associated Phospholipase A2 LP-LPA2 tumor necrosis factor-a TNF-a interleukins 6 and 10 IL6 and IL10 propeptide of type I procollagen PIP propeptide of procollagen type III PIIINP matrix metallopeptidases 9 and 2 MMP macrophage-colony stimulating factor MCSF growth differentiation factor-15 GDF-15 N-terminal pro b-type natriuretic peptide NT-proBNP and galectin-3
At 0 3 6 and 12 months the investigators will measure
1 Carotid-femoral pulse wave velocity PWV msec using tonometry by Complior SP ALAM and augmentation index AI by the method of arteriography Arteriograph TensioMed
2 Perfused boundary region PBR micrometers of the sublingual arterial microvessels ranged from 5-25 micrometers using Sideview Darkfield imaging Microscan Glycocheck Increased PBR is considered an accurate non invasive index of reduced endothelial glucocalyx thickness
3 Coronary flow reserve CFR in the left anterior descending artery after infusion of adenosine using Doppler echocardiography
4 Determination of the following parameters in blood glucose insulin free fatty acids triglycerides glycerol C reactive protein CRP transforming growth factor-b TGF-b Lipoprotein-Associated Phospholipase A2 LP-LPA2 tumor necrosis factor-a TNF-a interleukins 6 and 10 IL6 and IL10 propeptide of type I procollagen PIP propeptide of procollagen type III PIIINP matrix metallopeptidases 9 and 2 MMP macrophage-colony stimulating factor MCSF growth differentiation factor-15 GDF-15 N-terminal pro b-type natriuretic peptide NT-proBNP and galectin-3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None