Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies

Not Applicable

Recruiting

• Conditions: Coeliac Disease
• Interventions: Other: Standard of care; Other: Dietary intervention; Diagnostic Test: Cardiovascular risk-related parameters

• Registration Number: NCT05530070
• Lead Sponsor: University of Pecs

Brief 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.

Detailed Description

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 Timeline

• Study First Submitted: 2022-08-03
• Study Start: 2022-09-01
• Study First Submitted QC: 2022-09-04
• Study First Posted: 2022-09-07
• Status Verified: 2024-05
• Last Update Submitted: 2025-01-18
• Last Update Posted: 2025-01-22
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Standard of care	Patients randomized to the standard of care group.
Dietary intervention	Dietary intervention	Patients randomized to the dietary intervention group.
Dietary intervention	Cardiovascular risk-related parameters	Patients randomized to the dietary intervention group.
Standard of care	Cardiovascular risk-related parameters	Patients randomized to the standard of care group.

Primary Outcome Measures

Name	Time	Method
Percent body fat	1 year	Percent body fat in percentage measured by an InBody 770 body composition analyzer.

Secondary Outcome Measures

Name	Time	Method
Iron level	1 year	Iron level in µmol/L.
Body fat mass	1 year	Body fat mass in kilograms measured by an InBody 770 body composition analyzer.
Urea level	1 year	Urea level in mmol/L.
Creatinine level	1 year	Creatinine level in µmol/L.
Sodium level	1 year	Sodium level in mmol/L.
Potassium level	1 year	Potassium level in mmol/L.
Calcium level	1 year	Calcium level in mmol/L.
Vitamin D	1 year	Vitamin D level in ng/mL.
Vitamin B12	1 year	Vitamin B12 level in pg/mL.
Folic acid level	1 year	Folic acid level in µg/L.
Waist circumference	1 year	CV risk assessment will be performed by measuring waist circumference in centimeters.
Blood pressure	1 year	CV risk assessment will be performed by measuring blood pressure in Hgmm.
Fatty liver disease	1 year	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).
Cardiovascular risk assessment	1 year	CV risk assessment will be performed by the Systematic Coronary Risk Evaluation (SCORE) chart.
Coeliac disease-related symptoms	1 year	CD-related symptoms will be assessed by the Celiac Symptom Index (CSI).
Coeliac disease-specific quality of life	1 year	CD-specific quality of life questionnaire will be also used (Celiac Disease Quality of Life (CD-QoL).
Disease activity	1 year	Disease activity will be estimated by tissue transglutaminase (tTG) levels.
Sarcopenia	1 year	Sarcopenia will be assessed based on body composition and handgrip strength via handgrip dynamometer.
Triglyceride level	1 year	Triglyceride level in mmol/L.
Cholesterol level	1 year	Cholesterol (total, HDL and LDL lipoproteins) level in mmol/L.
Fasting glucose level	1 year	Fasting glucose level in mmol/L.
Fasting insulin level	1 year	Fasting insulin level in mmol/L.
Haemoglobin (Hb) A1c level	1 year	HbA1c level in percentage.
Homeostasis Model Assessment (HOMA) index	1 year	HOMA index
Bilirubin level	1 year	Bilirubin level in µmol/L.
Uric acid level	1 year	Uric acid µmol/L.
Ferritin level	1 year	Ferritin level in µg/L.
Transferrin level	1 year	Transferrin level in g/L.
Transferrin saturation	1 year	Transferrin saturation in percentage.
International Normalized Ratio (INR)	1 year	INR
Aspartate aminotransferase level	1 year	Aspartate aminotransferase level in U/L.
Alanine aminotransferase level	1 year	Alanine aminotransferase in U/L.
Fibrosis-4 (FIB-4) Index	1 year	FIB-4 Index for liver fibrosis.
Total protein level	1 year	Total protein level in g/L.
Albumin level	1 year	Albumin level in g/L.
Immunoglobulins	1 year	Immunoglobulins in U/mL.
High-sensitivity C-reactive protein (hs-CRP) level	1 year	hs-CRP level in mg/L.
Fibrinogen level	1 year	Fibrinogen level in g/L.
Blood counts	1 year	Blood counts in Giga/L.
Homocysteine levels	1 year	Homocysteine levels in µmol/L.
Interleukin-6 levels	1 year	Interleukin-6 levels in ng/L.
Leptin levels	1 year	Leptin levels in ng/mL.
Ghrelin levels	1 year	Ghrelin levels in pg/mL.
Adiponectin levels	1 year	Adiponectin levels in µg/mL.
Galectin-3 levels	1 year	Galectin-3 levels in ng/mL.
Dietary interview	1 year	Dietary adherence will be determined by dietary interview provided by an expertise dietitian.
Celiac Disease Adherence Test	1 year	Dietary adherence will be determined by the Celiac Disease Adherence Test (CDAT).
Coeliac-specific antibodies	1 year	Dietary adherence will be determined by coeliac-specific antibodies (tissue transglutaminase (tTG) immunoglobulin (Ig) A/IgG and endomysium antibody levels (EMA) IgA) in U/mL.
Urine gluten immunogenic peptide	1 year	Dietary adherence will be determined by urine gluten immunogenic peptide (GIP) measurement.
Diet composition	1 year	The composition of a GFD will be evaluated with the indicator of adherence to the Mediterranean diet, the Mediterranean Diet Score (MDS).
Body height	1 year	Height in centimeters measured by a stadiometer.
Body weight	1 year	Weight in kilograms measured by an InBody 770 body composition analyzer.
Body mass index	1 year	Body mass index in kg/m2 calculated by an InBody 770 body composition analyzer.
Skeletal muscle mass	1 year	Skeletal muscle mass in kilograms measured by an InBody 770 body composition analyzer.
Visceral fat area	1 year	Visceral fat area in cm2 measured by an InBody 770 body composition analyzer.
Total body water	1 year	Total body water in liters measured by an InBody 770 body composition analyzer.

Trial Locations

Locations (1)

First Department of Medicine, Medical School, University of Pécs; 🇭🇺 Pécs, Baranya, Hungary