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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with uncontrolled diabetes mellitus | Patients with uncotrolled tyre 1 or type 2 diabetes mellitus | ||
| Patients with controlled diabetes mellitus | Patients with controlled type 1 or type 2 diabetes mellitus |
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| Measure | Description | Time Frame |
|---|---|---|
| Differences in pulse wave velocity at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication. | Differences in pulse wave velocity (PWV, m/sec) using tonometry at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication. | Baseline, 3 months, 6 months, and 12 months. |
| Differences in augmentation index at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication. | Differences in augmentation index (AI,%) using oscillometry at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication. | Baseline, 3 months, 6 months, and 12 months. |
| Differences in endothelial glycocalyx at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication. | Differences in endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication. High PBR values represent reduced glycocalyx thickness. | Baseline, 3 months, 6 months, and 12 months. |
| Differences in flow mediated dilation (FMD) at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication. | Differences in flow mediated dilatation (FMD) of the brachial artery at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication. | Baseline, 3 months, 6 months, and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial glycocalyx and pulse wave velocity. | Association of endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels with pulse wave velocity (PWV, m/sec) after optimization of antidiabetic medication. | Baseline, 3 months, 6 months, and 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of 30 patients with uncontrolled type 1 diabetes and 30 patients with uncontrolled type 2 diabetes.
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| Name | Affiliation | Role |
|---|---|---|
| Ignatios Ikonomidis, MD | 2nd Cardiology Department, University of Athens, Greece | Principal Investigator |
| George Pavlidis, MD | 2nd Cardiology Department, University of Athens, Greece | Principal Investigator |
| Vaia Lambadiari, MD | 2nd Department of Internal Medicine, University of Athens, Greece | Principal Investigator |
| Fotini Kousathana, MD | 2nd Department of Internal Medicine, University of Athens, Greece | Principal Investigator |
| Constantinos Tymbas, MD | 2nd Cardiology Department, University of Athens, Greece | Principal Investigator |
| George Dimitriadis, MD | 2nd Department of Internal Medicine, University of Athens, Greece | Principal Investigator |
| John Lekakis, MD | 2nd Cardiology Department, University of Athens, Greece | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ''Attikon'' University General Hospital | Athens | Attica | 12462 | Greece |
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| Endothelial glycocalyx and coronary flow reserve. |
Association of endothelial glycocalyx as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels with coronary flow reserve (CFR) after optimization of antidiabetic medication. |
| Baseline, 3 months, 6 months, and 12 months. |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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