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RECRUITING
NCT05530070
NA

Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies

Sponsor: University of Pecs

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

190

Start Date

2022-09-01

Completion Date

2026-12

Last Updated

2025-01-22

Healthy Volunteers

No

Conditions

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.

Locations (1)

First Department of Medicine, Medical School, University of Pécs

Pécs, Baranya, Hungary