Coagulation Disorder, Endothelial Dysfunction, Inflammation, Insulin Resistance, Metabolic Disturbance, Psoriasis, Thrombocyte Disorders
Conditions
Keywords
Psoriasis, Endothelial dysfunction, Inflammation, Insulin resistance, Biologic therapy
Brief summary
A cross-sectional study will be conducted, which will include 80 young patients with psoriasis, aged 30-45 years, treated with five different types of antipsoriatic treatment, and 20 healthy patients. All 100 subjects will be subjected to anthropometric measurements, blood will be collected for laboratory tests, and an imaging test will be performed to determine the function of the endothelium and arterial stiffness. The results will then be statistically analyzed.
Detailed description
Research design: A cross-sectional study will be conducted, which will include 80 young patients with psoriasis, aged 30-45 years, without other chronic diseases, treated with five different types of treatment (local therapy, methotrexate, inhibitor of tumor necrosis factor α, inhibitor of interleukin 17 and inhibitor of interleukin 23), and 20 healthy patients aged 30-45 years. All 100 subjects will be subjected to anthropometric measurements (measurement of weight, height, systolic and diastolic blood pressure, heart rate, waist circumference), blood will be collected for laboratory tests (full blood count with differential, CRP, serum electrolytes, lipid panel, fasting glucose, HbA1c, alanine aminotransferase, aspartate aminotransferase, creatinine, urea, TNF-alpha, IL-6, IL-12, IL-17, IL-23, hsCRP, IFN-gamma, TRANCE, TRAIL, GDF-15, D-dimer, fibrinogen, overall haemostasis potential, overall coagulation potential, VCAM-1, ECAMs), and an imaging test (flow-mediated dilation and measurement of pulse wave velocity) will be performed to determine the function of the endothelium and arterial stiffness. The results will then be statistically analyzed. Aim of the study: The impact of chronic systemic inflammation in psoriasis on subclinical defects in the cardiovascular system (endothelial dysfunction, arterial stiffness, insulin resistance, platelet activation, and coagulation activation) and their effects on each other will be studied. In addition, the effect of the five main types of psoriasis treatment on all listed subclinical defects of the cardiovascular system will be investigated. Moreover, it will be investigated whether the type of treatment affects systemic inflammation in psoriasis in the same manner. Expected results: It is expected that all five groups of patients will differ from each other in terms of the degree of subclinical impairment of the cardiovascular system, depending on the expression of psoriasis and the type of treatment they receive. This will form the basis for establishing preventive measures against cardiovascular diseases in patients with psoriasis.
Interventions
None listed
Sponsors
University Medical Centre Ljubljana
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
30 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
\- patients with psoriasis aged 30 to 45 years in stable phase of the disease for at least last 6 months
Exclusion criteria
* any treatment besides treatment of psoriasis * carotid disease * heart failure * atrial fibrillation * diabetes type 1 or 2 * cardiovascular event in the past * chronic kidney disease stage 3, 4, 5 or end-stage kidney disease * psoriatic arthritis or any other rheumatic disease * malignancy * menopause in women * other chronic inflammatory diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arterial function - endothelial function | through study completion, an average of 6 months | Endothelial function (flow-mediated dilation) |
| Arterial function - arterial stiffness | through study completion, an average of 6 months | Arterial stiffness (pulse wave velocity) |
| Endothelial activation | through study completion, an average of 6 months | Circulating markers of endothelial activation (E-selectin, vascular cell adhesion molecule-1 (VCAM-1), Endothelial cell adhesion molecules (ECAMs)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic disturbances | through study completion, an average of 6 months | Parameters of (pre)metabolic syndrome (TyG (triglyceride-glucose index)) |
| Liver steatosis | through study completion, an average of 6 months | Laboratory markers (aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), Fib4 score (Fibrosis-4)) |
| Coagulation | through study completion, an average of 6 months | Circulating markers of coagulation activation (D-dimer, fibrinogen) |
| Inflammation | through study completion, an average of 6 months | Circulating markers of inflammation (tumor necrosis factor-alpha (TNF-alpha), interleukin (IL)-6, IL-12, IL-17, IL-23, high sensitivity C-reactive protein (hs-CRP), interferon-gamma, TNF-related activation-inducing ligand (TRANCE), TNF-related apoptosis-inducing ligand (TRAIL), Growth/differentiation factor-15 (GDF-15), neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR)) |
| Activation of coagulation | through study completion, an average of 6 months | Coagulation assay (overall coagulation potential (OCP) assay) |
| Platelet activation (1) | through study completion, an average of 6 months | Circulating markers of platelet activation (mean platelet volume (MPV) |
| Platelet activation (2) | through study completion, an average of 6 months | Circulating markers of platelet activation (P-selectin) |
| Activation of hemostasis | through study completion, an average of 6 months | Hemostatic assay (overall hemostasis potential (OHP) assay) |
| Insulin resistance | through study completion, an average of 6 months | Circulating markers of insulin resistance (fasting glucose, insulin), HOMA-IR equation (Homeostatic Model Assessment for Insulin Resistance) |
| Metabolic disturbances - dyslipidemia | through study completion, an average of 6 months | Parameters of (pre)metabolic syndrome (lipid panel) |
Countries
Slovenia
Outcome results
None listed