Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies

University of Pecs190 enrolled

Overview

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.

The global prevalence of coeliac disease (CD) is increasing, which contributes to the disease's significant public health care burden. Body composition and metabolic parameters of coeliac patients differ from the healthy population. Patients with non-classical CD are not necessarily lean; they usually have normal body weight but can be even overweight or obese. In coeliac patients, bodyweight tends to elevate, whereas the body composition changes unfavourably during a gluten-free diet (GFD). A reason for gaining weight is the improvement of malabsorption but an important contributor is the nutrient composition of the GFD, which generally has a high calorie density with high carbohydrate and fat content while being low in fibre. While terminating or mitigating the inflammatory process - if done without adequate dietary control - a GFD can readily lead to weight gain and unfavourably metabolic consequences (e.g., dyslipidemia, fatty liver disease, insulin resistance). The result can be an increase in cardiovascular risk in CD patients with a normal or high body weight at diagnosis. However, limited information is available on the cardiovascular (CV) risk in coeliac disease, and the data are controversial. This study examines the body composition and cardiovascular risk-related metabolic parameters at the diagnosis and on a gluten-free diet in a Hungarian cohort of CD patients. The randomised controlled trial (RCT) investigates the effect of structured, repeated, group-based dietary education on the examined metabolic parameters and body composition. This study aims to draw attention to a new aspect of the management of CD patients: from a metabolic and cardiovascular point of view. Findings will help to identify which parameters are beneficial to optimize and re-assess during follow-up in CD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Conditions

Coeliac Disease

Interventions

Dietary interventionOTHER

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 careOTHER

Patients will receive standard of care and baseline dietary education.

Cardiovascular risk-related parametersDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria (applies to all subjects): * Age should be over 18 years. * Blood collection must be indicated with medical conditions. * Signed informed consent. Inclusion Criteria (applies to specific cohorts of patients): * 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). * The newly diagnosed CD patients should be on a gluten-containing diet. * Patients following a GFD for at least 1 year should exhibit good dietary adherence. * In the randomized controlled trial (RCT), strict dietary adherence will be established based on CD-specific serology (normal level of antibodies), urine gluten immunogenic peptides (negative urine test), and dietary interview (convincing knowledge on the GFD and positive attitude towards strict adherence). Adherence to the mediterranean diet should be suboptimal (≤ 8 Medietrranean Diet Score). RCT-patients must have internet access and must be capable to attend the online sessions for 1 year. * Control subjects should be free from CD according to the recent guidelines and should be on a gluten-containing diet. Exclusion Criteria: * Chronic conditions: * 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. * Any acute diseases or acute deterioration of underlying chronic conditions. * Diseases that may be associated with clinically relevant malabsorption. * Refractory CD. * Pregnancy, lactation. * Patients unable to understand the essentials of the informed consent. * Lack of consent or withdrawal of consent.

Locations (1)

First Department of Medicine, Medical School, University of Pécs

Pécs, Baranya, Hungary

RECRUITING

Outcomes

Primary Outcomes

Percent body fat

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

Time frame: 1 year

Secondary Outcomes

Waist circumference

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

Time frame: 1 year

Blood pressure

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

Time frame: 1 year

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

Cardiovascular risk assessment

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

Time frame: 1 year

Coeliac disease-related symptoms

CD-related symptoms will be assessed by the Celiac Symptom Index (CSI).

Time frame: 1 year

Coeliac disease-specific quality of life

CD-specific quality of life questionnaire will be also used (Celiac Disease Quality of Life (CD-QoL).

Time frame: 1 year

Disease activity

Disease activity will be estimated by tissue transglutaminase (tTG) levels.

Central Contacts

Judit Bajor, MD, PhD

CONTACT

+36 72 536 000 bajor.judit@pte.hu

Data from ClinicalTrials.gov

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