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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Dietary intervention

    Other intervention

    Patients will participate in a structured, group-based dietary counseling. Consultations will be organized online (Zoom meeting) lasting approximately 60 min/occasion. The intervention will include 6 sessions for 1 year (monthly for 5 months and finally at month 9). The aim of the counseling is to maintain a GFD and to develop a healthy lifestyle, in line with the Mediterranean diet.

  • Standard of care

    Other intervention

    Patients will receive standard of care and baseline dietary education.

  • Cardiovascular risk-related parameters

    Diagnostic test

    Anthropometric measurements (body height, body composition assessment-InBody 770), questionnaires (symptoms, quality of life, dietary adherence, diet quality, cardiovascular risk), assessment of sarcopenia (handgrip dynamometer), urine collection (dietary adherence - urine gluten immunogenic peptide detection), blood collection (immunological tests, hormone levels complemented with routine laboratory panel), transabdominal US examination to assess the extent of fatty liver disease.

Treatment groups

190 Participants
are divided into 2 treatment groups
Group A: Dietary interventionActive comparator 2 interventions
Group B: Standard of careActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Percent body fat

Percent body fat in percentage measured by an InBody 770 body composition analyzer.

Time frame
1 year

Secondary outcomes

1

Waist circumference

CV risk assessment will be performed by measuring waist circumference in centimeters.

Time frame
1 year
2

Blood pressure

CV risk assessment will be performed by measuring blood pressure in Hgmm.

Time frame
1 year
3

Fatty liver disease

Transabdominal ultrasonography will be used to assess the extent of fatty liver disease (based on non-alcoholic fatty liver disease-liver fat score (NAFLD-LFS), with a score range of 0-3).

Time frame
1 year
4

Cardiovascular risk assessment

CV risk assessment will be performed by the Systematic Coronary Risk Evaluation (SCORE) chart.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pecs

Lead sponsor

Source ClinicalTrials.gov
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