Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies
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- Who runs it
- University of Pecs
- Trial code
- NCT05530070
- Record updated
- 22 January 2025
- Original description
This investigation examines the most important cardiovascular risk factors (e.g., metabolic parameters, body composition) and their changes in coeliac disease. The series of studies allow to assess body composition and cardiovascular risk-related metabolic parameters of newly diagnosed and treated coeliac patients in their complexity and to test if they change during therapy. The interventional part of the investigation aims to answer the question if a dietary intervention mitigates the unfavorable effects of unbalanced diet.Read full original descriptionShow less
This investigation examines the most important cardiovascular risk factors (e.g., metabolic parameters, body composition) and their changes in coeliac disease. The series of studies allow to assess body composition and cardiovascular risk-related metabolic parameters of newly diagnosed and treated coeliac patients in their complexity and to test if they change during therapy. The interventional part of the investigation aims to answer the question if a dietary intervention mitigates the unfavorable effects of unbalanced diet.
Inclusion: Age should be over 18 years; Blood collection must be indicated with medical conditions; Signed informed consent; The diagnosis of CD should be set up according to the current guidelines (based on serology and histology in adults or as per the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) guideline in children); The newly diagnosed CD patients should be on a gluten-containing diet; Patients following a GFD for at least 1 year should exhibit good dietary adherence; In the randomized controlled trial (RCT), strict dietary adherence will be established based on CD-specific serology (normal level of antibodies), urine gluten immunogenic peptides (negative urine test), and dietary interview (convincing knowledge on the GFD and positive attitude towards strict adherence). Adherence to the mediterranean diet should be suboptimal (≤ 8 Medietrranean Diet Score). RCT-patients must have internet access and must be capable to attend the online sessions for 1 year; Control subjects should be free from CD according to the recent guidelines and should be on a gluten-containing diet.
Exclusion: Chronic conditions:; Estimated glomerular filtration rate calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula is <60mL/min/1.73m2 (CKD3 or more severe kidney failure); Liver cirrhosis in Child-Pugh class B-C; Heart failure (New York Heart Association (NYHA) III-IV); Active malignant diseases; Any acute diseases or acute deterioration of underlying chronic conditions; Diseases that may be associated with clinically relevant malabsorption; Refractory CD; Pregnancy, lactation; Patients unable to understand the essentials of the informed consent; Lack of consent or withdrawal of consent.