Diabetes Mellitus Clinical Trial
Official title:
Changes in Arterial Stiffness and Endothelial Glycocalyx in Patients With Poorly Controlled Diabetes Mellitus Type 1 or Type 2 After Optimization of Antidiabetic Medication.
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. The purpose of this study is to investigate changes in arterial stiffness and endothelial glycocalyx thickness in patients with poorly controlled diabetes mellitus type 1 or type 2 after glycemic control by optimal medication.
The investigators will study two groups matched for age and sex: 30 patients with
uncontrolled type 1 diabetes and 30 patients with uncontrolled type 2 diabetes. Individuals
should not be treated with statins, beta-blockers, ACE inhibitors, sartans, hormonal
preparations, drugs that interfere with the function of platelets and hemostasis.
Furthermore, they should not have heart failure, nephropathy and retinopathy. 10 people will
remain uncontrolled after the expiration of 3 months after the modification of antidiabetic
medication used as a control group .
At 0, 3, 6 and 12 months the investigators will measure:
1. Carotid-femoral pulse wave velocity (PWV, m/sec) and augmentation index (AI%) by the
method of arteriography (Arteriograph, TensioMed) and Complior (SP ALAM).
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. Flow mediated dilatation (FMD) of the brachial artery.
4. Determination of 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), IL6
and IL10 (interleukins), 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.
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