Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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, 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).
  • - 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 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05530070
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Pecs
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Judit Bajor, MD, PhD
Principal Investigator Affiliation Division of Gastroenterology, First Department of Medicine, University of Pécs, 7624 Pécs, Hungary
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Hungary
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Coeliac Disease
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Dietary intervention

Patients randomized to the dietary intervention group.

Active Comparator: Standard of care

Patients randomized to the standard of care group.

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.

Contact a Trial Team

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International Sites

Pécs, Baranya, Hungary

Status

Recruiting

Address

First Department of Medicine, Medical School, University of Pécs

Pécs, Baranya, 7624

Site Contact

Judit Bajor, MD, PhD

bajor.judit@pte.hu

+36 72 536 000

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