Psoriasis
Conditions
Keywords
psoriasis, endothelial glycocalyx, arterial stiffness, coronary microcirculation, left ventricular myocardial deformation
Brief summary
The food supplement Endocalyx is considered to support the endothelial glycocalyx integrity by supplying sulfated polysaccharides, anti-oxidant enzymes and additional substrates for glycocalyx synthesis. The investigators will study the effect of Endocalyx on endothelial, vascular and left ventricular myocardial function in patients with psoriatic disease.
Detailed description
Sixty patients with psoriatic disease, who are referred to the outpatient psoriasis clinic of the Attikon University Hospital, will be randomized to receive food supplement Endocalyx (4 capsules per day) (n=30) or placebo (n=30) for 4 consecutive months.
Interventions
DIETARY_SUPPLEMENTFood supplement Endocalyx
Patients with psoriatic disease will be randomized to receive food supplement Endocalyx for 4 months.
DIETARY_SUPPLEMENTPlacebo
Patients with psoriatic disease will be randomized to receive placebo for 4 months.
Sponsors
University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Sixty patients with psoriatic disease will be randomized to receive food supplement Endocalyx (n=30) or placebo (n=30) for 4 consecutive months.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Caucasian patients with psoriatic disease (plaque-type psoriasis or psoriatic arthritis) * Body mass index ≥18.5 Kg/m2 * If female, patients must be non-pregnant and non-breastfeeding
Exclusion criteria
* History of acute coronary syndrome. Coronary artery disease will be excluded by a clinical history, examination and electrocardiogram. * Moderate or severe valve disease * Primary cardiomyopathies * Chronic obstructive pulmonary disease * Asthma * Chronic kidney disease * Liver failure * Malignancies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endocalyx effects on endothelial glycocalyx thickness | four months | Endocalyx effects on endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels using Sidestream Dark Field (SDF) imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endocalyx effects on arterial stiffness | four months | Endocalyx effects on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry. |
| Endocalyx effects on coronary microcirculation | four months | Endocalyx effects on coronary function as assessed by measuring coronary flow reserve of left anterior descending artery. Coronary flow reserve is estimated by Doppler echocardiography as the ratio of coronary flow velocity after bolus intravenous adenosine infusion to coronary flow velocity at rest. |
| Endocalyx effects on left ventricular myocardial function | four months | Endocalyx effects on left ventricular function as assessed by global longitudinal strain using speckle-tracking echocardiography. |
Countries
Greece
Contacts
Primary ContactIgnatios Ikonomidis, Professor
Backup ContactGeorge Pavlidis, PhD
Outcome results
None listed