Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies

NCT ID: NCT05530070

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2026-12-31

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.

Conditions

Coeliac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Dietary intervention

Patients randomized to the dietary intervention group.

Group Type: ACTIVE_COMPARATOR

Dietary intervention

Intervention Type: OTHER

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.

Cardiovascular risk-related parameters

Intervention Type: DIAGNOSTIC_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.

Standard of care

Patients randomized to the standard of care group.

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: OTHER

Patients will receive standard of care and baseline dietary education.

Cardiovascular risk-related parameters

Intervention Type: DIAGNOSTIC_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.

Interventions

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.

Intervention Type: OTHER

Standard of care

Patients will receive standard of care and baseline dietary education.

Intervention Type: OTHER

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age should be over 18 years.
• Blood collection must be indicated with medical conditions.
• Signed informed consent.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pecs

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judit Bajor, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Gastroenterology, First Department of Medicine, University of Pécs, 7624 Pécs, Hungary

Locations

First Department of Medicine, Medical School, University of Pécs

Pécs, Baranya, Hungary

Site Status: RECRUITING

Countries

Hungary

Central Contacts

Judit Bajor, MD, PhD

Role: CONTACT

bajor.judit@pte.hu

+36 72 536 000

Facility Contacts

Judit Bajor, MD, PhD

Role: primary

bajor.judit@pte.hu

+36 72 536 000

References

Capristo E, Addolorato G, Mingrone G, De Gaetano A, Greco AV, Tataranni PA, Gasbarrini G. Changes in body composition, substrate oxidation, and resting metabolic rate in adult celiac disease patients after a 1-y gluten-free diet treatment. Am J Clin Nutr. 2000 Jul;72(1):76-81. doi: 10.1093/ajcn/72.1.76.

Reference Type: BACKGROUND

PMID: 10871564 (View on PubMed)

Newnham ED, Shepherd SJ, Strauss BJ, Hosking P, Gibson PR. Adherence to the gluten-free diet can achieve the therapeutic goals in almost all patients with coeliac disease: A 5-year longitudinal study from diagnosis. J Gastroenterol Hepatol. 2016 Feb;31(2):342-9. doi: 10.1111/jgh.13060.

Reference Type: BACKGROUND

PMID: 26212198 (View on PubMed)

Nunes-Silva JG, Nunes VS, Schwartz RP, Mlss Trecco S, Evazian D, Correa-Giannella ML, Nery M, Queiroz MS. Impact of type 1 diabetes mellitus and celiac disease on nutrition and quality of life. Nutr Diabetes. 2017 Jan 9;7(1):e239. doi: 10.1038/nutd.2016.43.

Reference Type: BACKGROUND

PMID: 28067892 (View on PubMed)

Villanueva M, Oyarzun A, Leyton B, Gonzalez M, Navarro E, Canales P, Ossa C, Munoz MP, Bascunan KA, Araya M. Changes in Age at Diagnosis and Nutritional Course of Celiac Disease in the Last Two Decades. Nutrients. 2020 Jan 6;12(1):156. doi: 10.3390/nu12010156.

Reference Type: BACKGROUND

PMID: 31935859 (View on PubMed)

Melini V, Melini F. Gluten-Free Diet: Gaps and Needs for a Healthier Diet. Nutrients. 2019 Jan 15;11(1):170. doi: 10.3390/nu11010170.

Reference Type: BACKGROUND

PMID: 30650530 (View on PubMed)

Costa A, Brito GAP. Anthropometric Parameters in Celiac Disease: A Review on the Different Evaluation Methods and Disease Effects. J Nutr Metab. 2019 Sep 9;2019:4586963. doi: 10.1155/2019/4586963. eCollection 2019.

Reference Type: BACKGROUND

PMID: 31583132 (View on PubMed)

Tucker E, Rostami K, Prabhakaran S, Al Dulaimi D. Patients with coeliac disease are increasingly overweight or obese on presentation. J Gastrointestin Liver Dis. 2012 Mar;21(1):11-5.

Reference Type: BACKGROUND

PMID: 22457854 (View on PubMed)

Suarez-Gonzalez M, Bousono Garcia C, Jimenez Trevino S, Iglesias Cabo T, Diaz Martin JJ. Influence of nutrition education in paediatric coeliac disease: impact of the role of the registered dietitian: a prospective, single-arm intervention study. J Hum Nutr Diet. 2020 Dec;33(6):775-785. doi: 10.1111/jhn.12800. Epub 2020 Aug 12.

Reference Type: BACKGROUND

PMID: 32790023 (View on PubMed)

Marciniak M, Szymczak-Tomczak A, Mahadea D, Eder P, Dobrowolska A, Krela-Kazmierczak I. Multidimensional Disadvantages of a Gluten-Free Diet in Celiac Disease: A Narrative Review. Nutrients. 2021 Feb 16;13(2):643. doi: 10.3390/nu13020643.

Reference Type: BACKGROUND

PMID: 33669442 (View on PubMed)

Vereczkei Z, Szakacs Z, Peresztegi MZ, Lemes K, Hagymasi K, Dako S, Dako E, Lada S, Faluhelyi N, Szekeres G, Pasztor G, Farkas N, Par G, Mezosi E, Bajor J. Influence of a structured, 1-year-long dietary intervention regarding body composition and cardiovascular risk (ARCTIC) in coeliac disease: a protocol of a multicentre randomised controlled trial. BMJ Open. 2024 Oct 8;14(10):e084365. doi: 10.1136/bmjopen-2024-084365.

Reference Type: DERIVED

PMID: 39384235 (View on PubMed)

Vereczkei Z, Imrei M, Szakacs Z, Kovari B, Papp V, Lenart Z, Berki T, Szirmay B, Farkas N, Balasko M, Habon T, Hegyi P, Bajor J. Cardiovascular risk factors in coeliac disease (ARCTIC): a protocol of multicentre series of studies. BMJ Open. 2023 Sep 13;13(9):e068989. doi: 10.1136/bmjopen-2022-068989.

Reference Type: DERIVED

PMID: 37709338 (View on PubMed)

Other Identifiers

27521-5/2022/EÜIG

Identifier Type: -

Identifier Source: org_study_id