Coeliac DiseaseARCTICNCT05530070
Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies
A study testing Dietary intervention and Cardiovascular risk-related parameters in people with Coeliac Disease, run by University of Pecs at 1 site in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coeliac Disease
- What is being tested?
- Dietary intervention and Cardiovascular risk-related parameters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteHungary
- Study dates
- 1 Sep 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
First Department of Medicine, Medical School, University of Pécs
Pécs, Baranya, 7624
Judit Bajor, MD, PhD, +36 72 536 000, bajor.judit@pte.hu
About this study
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.
Read the 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
- Being tested
- Dietary intervention, Standard of care, Cardiovascular risk-related parameters
- Keywords
- coeliac disease, cardiovascular risk, body composition, dietary intervention
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention | Active comparator | Patients randomized to the dietary intervention group. Receives: Other: Dietary intervention; Diagnostic Test: Cardiovascular risk-related parameters |
| Standard of care | Active comparator | Patients randomized to the standard of care group. Receives: Other: Standard of care; Diagnostic Test: Cardiovascular risk-related parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent body fat
Percent body fat in percentage measured by an InBody 770 body composition analyzer.
Measured: 1 year
Secondary outcomes (56)
Waist circumference
CV risk assessment will be performed by measuring waist circumference in centimeters.
Measured: 1 year
Blood pressure
CV risk assessment will be performed by measuring blood pressure in Hgmm.
Measured: 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).
Measured: 1 year
Cardiovascular risk assessment
CV risk assessment will be performed by the Systematic Coronary Risk Evaluation (SCORE) chart.
Measured: 1 year
Coeliac disease-related symptoms
CD-related symptoms will be assessed by the Celiac Symptom Index (CSI).
Measured: 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).
Measured: 1 year
Disease activity
Disease activity will be estimated by tissue transglutaminase (tTG) levels.
Measured: 1 year
Sarcopenia
Sarcopenia will be assessed based on body composition and handgrip strength via handgrip dynamometer.
Measured: 1 year
Triglyceride level
Triglyceride level in mmol/L.
Measured: 1 year
Cholesterol level
Cholesterol (total, HDL and LDL lipoproteins) level in mmol/L.
Measured: 1 year
Fasting glucose level
Fasting glucose level in mmol/L.
Measured: 1 year
Fasting insulin level
Fasting insulin level in mmol/L.
Measured: 1 year
Haemoglobin (Hb) A1c level
HbA1c level in percentage.
Measured: 1 year
Homeostasis Model Assessment (HOMA) index
HOMA index
Measured: 1 year
Bilirubin level
Bilirubin level in µmol/L.
Measured: 1 year
Uric acid level
Uric acid µmol/L.
Measured: 1 year
Urea level
Urea level in mmol/L.
Measured: 1 year
Creatinine level
Creatinine level in µmol/L.
Measured: 1 year
Sodium level
Sodium level in mmol/L.
Measured: 1 year
Potassium level
Potassium level in mmol/L.
Measured: 1 year
Calcium level
Calcium level in mmol/L.
Measured: 1 year
Vitamin D
Vitamin D level in ng/mL.
Measured: 1 year
Vitamin B12
Vitamin B12 level in pg/mL.
Measured: 1 year
Folic acid level
Folic acid level in µg/L.
Measured: 1 year
Iron level
Iron level in µmol/L.
Measured: 1 year
Ferritin level
Ferritin level in µg/L.
Measured: 1 year
Transferrin level
Transferrin level in g/L.
Measured: 1 year
Transferrin saturation
Transferrin saturation in percentage.
Measured: 1 year
International Normalized Ratio (INR)
INR
Measured: 1 year
Aspartate aminotransferase level
Aspartate aminotransferase level in U/L.
Measured: 1 year
Alanine aminotransferase level
Alanine aminotransferase in U/L.
Measured: 1 year
Fibrosis-4 (FIB-4) Index
FIB-4 Index for liver fibrosis.
Measured: 1 year
Total protein level
Total protein level in g/L.
Measured: 1 year
Albumin level
Albumin level in g/L.
Measured: 1 year
Immunoglobulins
Immunoglobulins in U/mL.
Measured: 1 year
High-sensitivity C-reactive protein (hs-CRP) level
hs-CRP level in mg/L.
Measured: 1 year
Fibrinogen level
Fibrinogen level in g/L.
Measured: 1 year
Blood counts
Blood counts in Giga/L.
Measured: 1 year
Homocysteine levels
Homocysteine levels in µmol/L.
Measured: 1 year
Interleukin-6 levels
Interleukin-6 levels in ng/L.
Measured: 1 year
Leptin levels
Leptin levels in ng/mL.
Measured: 1 year
Ghrelin levels
Ghrelin levels in pg/mL.
Measured: 1 year
Adiponectin levels
Adiponectin levels in µg/mL.
Measured: 1 year
Galectin-3 levels
Galectin-3 levels in ng/mL.
Measured: 1 year
Dietary interview
Dietary adherence will be determined by dietary interview provided by an expertise dietitian.
Measured: 1 year
Celiac Disease Adherence Test
Dietary adherence will be determined by the Celiac Disease Adherence Test (CDAT).
Measured: 1 year
Coeliac-specific antibodies
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.
Measured: 1 year
Urine gluten immunogenic peptide
Dietary adherence will be determined by urine gluten immunogenic peptide (GIP) measurement.
Measured: 1 year
Diet composition
The composition of a GFD will be evaluated with the indicator of adherence to the Mediterranean diet, the Mediterranean Diet Score (MDS).
Measured: 1 year
Body height
Height in centimeters measured by a stadiometer.
Measured: 1 year
Body weight
Weight in kilograms measured by an InBody 770 body composition analyzer.
Measured: 1 year
Body mass index
Body mass index in kg/m2 calculated by an InBody 770 body composition analyzer.
Measured: 1 year
Body fat mass
Body fat mass in kilograms measured by an InBody 770 body composition analyzer.
Measured: 1 year
Skeletal muscle mass
Skeletal muscle mass in kilograms measured by an InBody 770 body composition analyzer.
Measured: 1 year
Visceral fat area
Visceral fat area in cm2 measured by an InBody 770 body composition analyzer.
Measured: 1 year
Total body water
Total body water in liters measured by an InBody 770 body composition analyzer.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Sep 2022
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Coeliac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judit Bajor, MD, PhD, Principal investigator, Division of Gastroenterology, First Department of Medicine, University of Pécs, 7624 Pécs, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530070
- Sponsor's protocol ID
- 27521-5/2022/EÜIG
- Acronym
- ARCTIC
- Status last verified
- May 2024
- First submitted
- 3 Aug 2022
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10871564Newnham 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.
PubMed 26212198Nunes-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.
PubMed 28067892Villanueva 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.
PubMed 31935859Melini V, Melini F. Gluten-Free Diet: Gaps and Needs for a Healthier Diet. Nutrients. 2019 Jan 15;11(1):170. doi: 10.3390/nu11010170.
PubMed 30650530Costa 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.
PubMed 31583132Tucker 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.
PubMed 22457854Suarez-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.
PubMed 32790023Marciniak 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.
PubMed 33669442Vereczkei 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.
PubMed 39384235Vereczkei 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.
PubMed 37709338
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies
- ClinicalTrials.gov ID
- NCT05530070
- Acronym / sponsor ID
- ARCTIC / 27521-5/2022/EÜIG
- Conditions
- Coeliac Disease
- Keywords
- coeliac disease, cardiovascular risk, body composition, dietary intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention | Active comparator | Other: Dietary intervention, Diagnostic Test: Cardiovascular risk-related parametersPatients randomized to the dietary intervention group. |
| Standard of care | Active comparator | Other: Standard of care, Diagnostic Test: Cardiovascular risk-related parametersPatients randomized to the standard of care group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- Chronic conditions:
- Any acute diseases or acute deterioration of underlying chronic conditions.
- Diseases that may be associated with clinically relevant malabsorption.
- Refractory CD.
- Pregnancy, lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary interventionPatients 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 | Dietary intervention |
| Standard of carePatients will receive standard of care and baseline dietary education. | Other | Standard of care |
| Cardiovascular risk-related parametersAnthropometric 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. | Diagnostic test | Dietary intervention, Standard of care |
Primary outcome
Percent body fat
Time frame: 1 year
Percent body fat in percentage measured by an InBody 770 body composition analyzer.
56 secondary outcomes
Waist circumference
Time frame: 1 year
Blood pressure
Time frame: 1 year
Fatty liver disease
Time frame: 1 year
Cardiovascular risk assessment
Time frame: 1 year
Coeliac disease-related symptoms
Time frame: 1 year
Coeliac disease-specific quality of life
Time frame: 1 year
Disease activity
Time frame: 1 year
Sarcopenia
Time frame: 1 year
Triglyceride level
Time frame: 1 year
Cholesterol level
Time frame: 1 year
Fasting glucose level
Time frame: 1 year
Fasting insulin level
Time frame: 1 year
Haemoglobin (Hb) A1c level
Time frame: 1 year
Homeostasis Model Assessment (HOMA) index
Time frame: 1 year
Bilirubin level
Time frame: 1 year
Uric acid level
Time frame: 1 year
Urea level
Time frame: 1 year
Creatinine level
Time frame: 1 year
Sodium level
Time frame: 1 year
Potassium level
Time frame: 1 year
Calcium level
Time frame: 1 year
Vitamin D
Time frame: 1 year
Vitamin B12
Time frame: 1 year
Folic acid level
Time frame: 1 year
Iron level
Time frame: 1 year
Ferritin level
Time frame: 1 year
Transferrin level
Time frame: 1 year
Transferrin saturation
Time frame: 1 year
International Normalized Ratio (INR)
Time frame: 1 year
Aspartate aminotransferase level
Time frame: 1 year
Alanine aminotransferase level
Time frame: 1 year
Fibrosis-4 (FIB-4) Index
Time frame: 1 year
Total protein level
Time frame: 1 year
Albumin level
Time frame: 1 year
Immunoglobulins
Time frame: 1 year
High-sensitivity C-reactive protein (hs-CRP) level
Time frame: 1 year
Fibrinogen level
Time frame: 1 year
Blood counts
Time frame: 1 year
Homocysteine levels
Time frame: 1 year
Interleukin-6 levels
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Background: PubMed 10871564Capristo 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.
- Background: PubMed 26212198Newnham 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.
- Background: PubMed 28067892Nunes-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.
- Background: PubMed 31935859Villanueva 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.
- Background: PubMed 30650530Melini V, Melini F. Gluten-Free Diet: Gaps and Needs for a Healthier Diet. Nutrients. 2019 Jan 15;11(1):170. doi: 10.3390/nu11010170.
- Background: PubMed 31583132Costa 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.
- Background: PubMed 22457854Tucker 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.
- Background: PubMed 32790023Suarez-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.
- Background: PubMed 33669442Marciniak 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.
- Derived from this study: PubMed 39384235Vereczkei 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.
- Derived from this study: PubMed 37709338Vereczkei 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Judit Bajor, MD, PhD principal investigator
Division of Gastroenterology, First Department of Medicine, University of Pécs, 7624 Pécs, Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention and Cardiovascular risk-related parameters in people with Coeliac Disease, run by University of Pecs at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judit Bajor, MD, PhD (+36 72 536 000, bajor.judit@pte.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent body fat (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05530070, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.