Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05530070

Cardiovascular Risk Factors in Coeliac Disease: A Series of Studies Assessing Body Composition and Dietary Intervention Effects

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

Researchers are studying cardiovascular risk factors such as metabolic parameters and body composition in people with coeliac disease (CD). The study focuses on newly diagnosed and treated CD patients, aiming to understand how these factors change during therapy. It also explores whether a dietary intervention can reduce the negative effects of an unbalanced diet on cardiovascular health in this population. The research addresses the growing prevalence of CD and its impact on public health, highlighting differences in body composition and metabolism compared to healthy individuals. Participants receive either standard care with baseline dietary education or a structured, group-based dietary counseling program delivered online via Zoom. This counseling includes six sessions over one year (monthly for five months and a final session at month nine) to support maintaining a gluten-free diet and adopting a Mediterranean-style healthy lifestyle. The study examines how this intervention affects body composition and metabolic parameters related to cardiovascular risk. During the study, participants undergo various assessments including body measurements, questionnaires on symptoms, quality of life, diet adherence, and cardiovascular risk, as well as tests for muscle strength, urine analysis for gluten intake, blood tests for immune and hormone markers, and ultrasound scans to check for fatty liver disease. Researchers monitor changes in body fat percentage over one year and assess metabolic and cardiovascular health to better manage CD patients from a metabolic perspective. Participation includes ongoing follow-up and detailed evaluations to track health changes.

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.

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Trial Site Locations

Total: 1 location

1

First Department of Medicine, Medical School, University of Pécs

Pécs, Baranya, Hungary, 7624

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Research Team

J

Judit Bajor, MD, PhD

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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Published Research Related To This Trial

Changes in body composition, substrate oxidation, and resting metabolic rate in adult celiac disease patients after a 1-y gluten-free diet treatment.

E Capristo, G Addolorato, G Mingrone...

https://pubmed.ncbi.nlm.nih.gov/10871564

Adherence to the gluten-free diet can achieve the therapeutic goals in almost all patients with coeliac disease: A 5-year longitudinal study from diagnosis.

Evan D Newnham, Susan J Shepherd, Boyd J Strauss...

https://pubmed.ncbi.nlm.nih.gov/26212198

Influence of nutrition education in paediatric coeliac disease: impact of the role of the registered dietitian: a prospective, single-arm intervention study.

M Suárez-González, C Bousoño García, S Jiménez Treviño...

https://pubmed.ncbi.nlm.nih.gov/32790023

Influence of a structured, 1-year-long dietary intervention regarding body composition and cardiovascular risk (ARCTIC) in coeliac disease: a protocol of a multicentre randomised controlled trial.

Zsófia Vereczkei, Zsolt Szakács, Míra Zsófia Peresztegi...

https://pubmed.ncbi.nlm.nih.gov/39384235