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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 190 participants in total. It began in 2022-09-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Judit Bajor, MD, PhD
PRINCIPAL INVESTIGATOR
Division of Gastroenterology, First Department of Medicine, University of Pécs, 7624 Pécs, Hungary
Frequently Asked Questions
Who can join the NCT05530070 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coeliac Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05530070 currently recruiting?
Yes, NCT05530070 is actively recruiting participants. Contact the research team at bajor.judit@pte.hu for enrollment information.
Where is the NCT05530070 trial being conducted?
This trial is being conducted at Pécs, Hungary.
Who is sponsoring the NCT05530070 clinical trial?
NCT05530070 is sponsored by University of Pecs. The principal investigator is Judit Bajor, MD, PhD at Division of Gastroenterology, First Department of Medicine, University of Pécs, 7624 Pécs, Hungary. The trial plans to enroll 190 participants.