RECRUITINGINTERVENTIONAL

Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies

About This Trial

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.

Who May Be Eligible (Plain English)

Inclusion Criteria (applies to all subjects): - Age should be over 18 years. - Blood collection must be indicated with medical conditions. - Signed willing to sign a consent form. Inclusion Criteria (applies to specific cohorts of patients): - 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. Who Should NOT Join This Trial: - 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 willing to sign a consent form. - Lack of consent or withdrawal of consent. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria (applies to all subjects): * Age should be over 18 years. * Blood collection must be indicated with medical conditions. * Signed informed consent. Inclusion Criteria (applies to specific cohorts of patients): * 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 Criteria: * 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.

Treatments Being Tested

OTHER

Dietary intervention

Patients will participate in a structured, group-based dietary counseling. Consultations will be organized online (Zoom meeting) lasting approximately 60 min/occasion. The intervention will include 6 sessions for 1 year (monthly for 5 months and finally at month 9). The aim of the counseling is to maintain a GFD and to develop a healthy lifestyle, in line with the Mediterranean diet.

OTHER

Standard of care

Patients will receive standard of care and baseline dietary education.

DIAGNOSTIC_TEST

Cardiovascular risk-related parameters

Anthropometric measurements (body height, body composition assessment-InBody 770), questionnaires (symptoms, quality of life, dietary adherence, diet quality, cardiovascular risk), assessment of sarcopenia (handgrip dynamometer), urine collection (dietary adherence - urine gluten immunogenic peptide detection), blood collection (immunological tests, hormone levels complemented with routine laboratory panel), transabdominal US examination to assess the extent of fatty liver disease.

Locations (1)

First Department of Medicine, Medical School, University of Pécs

Pécs, Baranya, Hungary