Hemorheologic parameters in celiac disease and inflammatory bowel diseases: a prospective controlled study
Celiac disease, inflammatory bowel disease (Crohn’s disease and ulcerative colitis)
We will include 50 CD patients, 50 IBD patients, and 50 non-celiac, non-IBD control subjects (age- and sex-matched inclusion after recruiting CD and IBD patients) in the first phase of the study. Then, an interim analysis will be performed to assess power and establish the need for further recruitment. Questionnaires, interviews, urine collection, and blood sampling will be carried out on the day of recruitment. 1. Questionnaires will be applied, as follows: a thrombophilia questionnaire (assessing risk factors and history of venous and arterial thrombotic events) to all participants, Gastrointestinal Symptoms Rating Scale (GSRS) and self-reported dietary adherence (on a scale between 1 and 10 and following the work of Silvester published in 2016 in J Hum Nutr Diet) to CD patients, and Mayo score/Crohn's Disease Activity Index to IBD patients. 2. Venous blood samples will be collected to measure routine laboratory parameters (bilirubin, urea, creatinine, cholesterol (total, high-density and low-density lipoproteins), triglyceride, aspartate- aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, total protein, albumin, immunoglobulins, C-reactive protein, vitamin B12, prothrombin, thrombin time, activated partial thromboplastin time, fibrinogen, blood counts, erythrocyte sedimentation, antithrombin activity, protein C activity, protein S activity, antiphospholipid antibodies (lupus anticoagulans, cardiolipin IgG/A/M, B2-glycoprotein-I IgG/A/M, prothrombin IgG/A/M), celiac specific antibodies (tissue transglutaminase IgA/G, gliadin IgA, endomysium IgA)) and hemorheologic tests (erythrocyte aggregation and deformability, viscosity of whole blood and plasma). After preparation, remaining samples (whole blood and plasma) will be stored in the Biobank of Institute for Translational Medicine, University of Pécs at -80°C. 3. Mid-stream urine will be collected and stored at -80°C until processing. After preparation (centrifug
CD patients 1. Newly diagnosed or followed-up patients (with or without adhering to a gluten-free diet (GFD) 2. Aged ≥18 years 3. Diagnosis should meet the current guidelines (ESPHGAN, American College of Gastroenterology) IBD patients 1. Newly diagnosed and followed-up patients 2. Aged ≥18 years 3. Diagnosis should meet the current guidelines (ECCO) Non-CD, non-IBD controls 1. Aged ≥18 years 2. Celiac disease excluded (lack of symptoms and negative celiac-specific serology) 3. IBD excluded (lack of clinical, biochemical, endoscopic or radiologic signs of the disease)
1. Estimated glomerular filtration rate calculated with CKD-EPI formula <60 ml/min/1.73 m2 (CKD Stage 3 or more severe kidney failure) 2. Liver cirrhosis (Child-Pugh class B/C) 3. Heart failure (NYHA class III/IV) 4. Malignant diseases (except for cured cases) 5. Acute diseases within 2 weeks of sampling 6. Patients unable to understand the essentials of the informed consent