Changes in Arterial Stiffness and Endothelial Glycocalyx in Patients With Poorly Controlled Diabetes Mellitus Type 1 or Type 2 After Optimization of Antidiabetic Medication.
NCT ID: NCT03010956
Last Updated: 2018-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2014-11-30
2017-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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Patients with uncontrolled diabetes mellitus
Patients with uncotrolled tyre 1 or type 2 diabetes mellitus
No interventions assigned to this group
Patients with controlled diabetes mellitus
Patients with controlled type 1 or type 2 diabetes mellitus
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* congestive heart failure
* peripheral vascular disease
* liver or kidney failure
* history of alcohol or drug abuse
* treatment with statins, beta- blockers, ACE inhibitors or sartans
18 Years
70 Years
ALL
Yes
Sponsors
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University of Athens
OTHER
Responsible Party
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Ignatios Ikonomidis
Associate Professor in Cardiology
Principal Investigators
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Ignatios Ikonomidis, MD
Role: PRINCIPAL_INVESTIGATOR
2nd Cardiology Department, University of Athens, Greece
George Pavlidis, MD
Role: PRINCIPAL_INVESTIGATOR
2nd Cardiology Department, University of Athens, Greece
Vaia Lambadiari, MD
Role: PRINCIPAL_INVESTIGATOR
2nd Department of Internal Medicine, University of Athens, Greece
Fotini Kousathana, MD
Role: PRINCIPAL_INVESTIGATOR
2nd Department of Internal Medicine, University of Athens, Greece
Constantinos Tymbas, MD
Role: PRINCIPAL_INVESTIGATOR
2nd Cardiology Department, University of Athens, Greece
George Dimitriadis, MD
Role: PRINCIPAL_INVESTIGATOR
2nd Department of Internal Medicine, University of Athens, Greece
John Lekakis, MD
Role: PRINCIPAL_INVESTIGATOR
2nd Cardiology Department, University of Athens, Greece
Locations
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''Attikon'' University General Hospital
Athens, Attica, Greece
Countries
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Other Identifiers
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S-DM-ATTIKON
Identifier Type: -
Identifier Source: org_study_id
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