NCT05530070 Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies
| NCT ID | NCT05530070 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pecs |
| Condition | Coeliac Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2026-09 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
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 M