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Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies

NCT05530070 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2025-01-22

No results posted yet for this study

Summary

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

  • Coeliac Disease

Interventions

OTHER

Dietary 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.

OTHER

Standard of care

Patients will receive standard of care and baseline dietary education.

DIAGNOSTIC_TEST

Cardiovascular risk-related parameters

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.

Sponsors & Collaborators

  • University of Pecs

    lead OTHER

Principal Investigators

  • Judit Bajor, MD, PhD · Division of Gastroenterology, First Department of Medicine, University of Pécs, 7624 Pécs, Hungary

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05530070 on ClinicalTrials.gov