Investigating cardiovascular risks in coeliac disease patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This investigation examines key cardiovascular risk factors and their changes in patients with coeliac disease. It assesses body composition and metabolic parameters in newly diagnosed and treated coeliac patients, focusing on the impact of a gluten-free diet. The study includes a randomized controlled trial to evaluate whether a structured dietary intervention can mitigate the adverse effects associated with an unbalanced diet. The research aims to provide insights into the cardiovascular health of coeliac patients and the effectiveness of dietary management.

Why it matters

Who can join: the full rules

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.

Where it's running

• First Department of Medicine, Medical School, University of Pécs
  Pécs, Baranya, Hungary Recruiting

Study contacts

• Principal investigator: Judit Bajor, MD, PhD — Division of Gastroenterology, First Department of Medicine, University of Pécs, 7624 Pécs, Hungary
• Study coordinator: Judit Bajor, MD, PhD
• Email: bajor.judit@pte.hu
• Phone: +36 72 536 000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.