Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05530070

Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies

Led by University of Pecs · Updated on 2025-01-22

190

Participants Needed

1

Research Sites

221 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age should be over 18 years.
  • Blood collection must be indicated with medical conditions.
  • Signed informed consent.
  • Diagnosis of coeliac disease according to current guidelines (serology and histology or ESPGHAN guideline in children).
  • Newly diagnosed coeliac patients must be on a gluten-containing diet.
  • Patients on a gluten-free diet for at least 1 year must show good dietary adherence.
  • In the randomized trial, strict dietary adherence is required based on serology, urine tests, and dietary interview.
  • Adherence to the Mediterranean diet should be suboptimal (Mediterranean Diet Score ≤ 8).
  • Randomized trial patients must have internet access and be able to attend online sessions for 1 year.
  • Control subjects must be free from coeliac disease and on a gluten-containing diet.
Not Eligible

You will not qualify if you...

  • Estimated glomerular filtration rate less than 60 mL/min/1.73m2 (CKD stage 3 or worse).
  • Liver cirrhosis in Child-Pugh class B or C.
  • Heart failure classified as New York Heart Association (NYHA) III or IV.
  • Active malignant diseases.
  • Any acute illness or worsening of chronic conditions.
  • Diseases causing clinically significant malabsorption.
  • Refractory coeliac disease.
  • Pregnancy or breastfeeding.
  • Inability to understand the informed consent.
  • Lack of consent or withdrawal of consent.

AI-Screening

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Trial Site Locations

Total: 1 location

1

First Department of Medicine, Medical School, University of Pécs

Pécs, Baranya, Hungary, 7624

Actively Recruiting

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Research Team

J

Judit Bajor, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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