Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies
ConditionCoeliac Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pecs
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Dietary intervention
- Standard of care
- Cardiovascular risk-related parameters
Treatment groups
190 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov