Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies

NCT05530070 | Recruiting DMC

• 1 other identifier: 27521-5/2022/EÜIG
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Coeliac Disease

Keywords

coeliac disease; cardiovascular risk; body composition; dietary intervention

Outcome Measures

Primary Outcomes (1)

• Percent body fat

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

  1 year

Secondary Outcomes (56)

• Waist circumference

  1 year

• Blood pressure

  1 year

• Fatty liver disease

  1 year

• Cardiovascular risk assessment

  1 year

• Coeliac disease-related symptoms

  1 year

Study Arms (2)

Dietary intervention

ACTIVE COMPARATOR

Patients randomized to the dietary intervention group.

Other: Dietary intervention; Diagnostic Test: Cardiovascular risk-related parameters

Standard of care

ACTIVE COMPARATOR

Patients randomized to the standard of care group.

Other: Standard of care; Diagnostic Test: Cardiovascular risk-related parameters

Interventions

Dietary intervention 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.

Dietary intervention

Standard of care OTHER

Patients will receive standard of care and baseline dietary education.

Standard of care

Cardiovascular risk-related parameters 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.

Dietary intervention; Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

First Department of Medicine, Medical School, University of Pécs

Pécs, Baranya, 7624, Hungary

RECRUITING

Related Publications (11)

• 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.

  PMID: 10871564 BACKGROUND

• 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.

  PMID: 26212198 BACKGROUND

• 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.

  PMID: 28067892 BACKGROUND

• 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.

  PMID: 31935859 BACKGROUND

• 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.

  PMID: 30650530 BACKGROUND

• 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.

  PMID: 31583132 BACKGROUND

• 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.

  PMID: 22457854 BACKGROUND

• 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.

  PMID: 32790023 BACKGROUND

• 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.

  PMID: 33669442 BACKGROUND

• 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.

  PMID: 39384235 DERIVED

• 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.

  PMID: 37709338 DERIVED

MeSH Terms

Conditions

Celiac Disease

Interventions

Diet Therapy; Standard of Care

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Judit Bajor, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judit Bajor, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the study, the blinding of the participants is not possible. The blinding of the physicians, data managers and statisticians will be secured.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This trial is a series of three multicentric studies. It includes 1) a case-control study, which compares newly diagnosed CD patients (n=37) and CD patients on a GFD (n=99) to matched non-coeliac control subjects (n=136); 2) a prospective cohort study, which investigates how the outcomes change during a 1-year GFD started after diagnosis of CD (n=236); 3) an RCT, which investigates how a dietetic intervention (n=95) influences the outcomes, compared to standard of care (n=95), in CD patients following a strict GFD for at least 1 year. There will be no intervention for the sake of the study in the case-control and the cohort study. Parameters of interest will be assessed only once in the case-control study and twice in the cohort study. In the RCT, randomization will be carried out after the baseline dietary education and interview, in 1:1 allocation ratio. Parameters will be recorded at baseline and the end of the study.

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: September 7, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 22, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)