Evidence map›Paper›PMID 39384235›Full record

ArticleBMJ open2024

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.

Zsófia Vereczkei, Zsolt Szakács, Míra Zsófia Peresztegi, Klára Lemes, Krisztina Hagymási, Sarolta Dakó, Eszter Dakó, Szilvia Lada, Nándor Faluhelyi, Gábor Szekeres and 5 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05530070 (Cardiovascular Risk Factors in Coeliac Disease), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05530070 narecruitingnot on this map

Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies

TypeinterventionalSponsorUniversity of PecsRan2022 to 2026Enrolled190ConditionsCoeliac DiseaseArmsDietary intervention, Standard of care, Cardiovascular risk-related parameters
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Zsófia VereczkeiInstitute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.ORCID 0000-0002-8144-4628
Zsolt SzakácsFirst Department of Medicine, Medical Shcool, University of Pécs, Pécs, Hungary.
Míra Zsófia PeresztegiMedical Shcool, University of Pécs, Pécs, Hungary.
Klára LemesDepartment of Medicine, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, Hungary.
Krisztina HagymásiDepartment of Surgery, Transplantation and Gastroenterology, Faculty of Medicine, Semmelweis University, Budapest, Hungary.
Sarolta DakóDepartment of Surgery, Transplantation and Gastroenterology, Faculty of Medicine, Semmelweis University, Budapest, Hungary.
Eszter DakóDepartment of Surgery, Transplantation and Gastroenterology, Faculty of Medicine, Semmelweis University, Budapest, Hungary.
Szilvia LadaDepartment of Medicine, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, Hungary.
Nándor FaluhelyiDepartment of Radiology, Medical School, University of Pécs, Pécs, Hungary.
Gábor SzekeresDepartment of Radiology, Medical School, University of Pécs, Pécs, Hungary.
Gyula PásztorDepartment of Radiology, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, Hungary.
Nelli FarkasInstitute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.
Gabriella PárFirst Department of Medicine, Medical Shcool, University of Pécs, Pécs, Hungary.
Emese MezősiFirst Department of Medicine, Medical Shcool, University of Pécs, Pécs, Hungary.
Judit BajorFirst Department of Medicine, Medical Shcool, University of Pécs, Pécs, Hungary bajor.judit@pte.hu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCoeliac disease (CD) affects 1% of the population worldwide. The only available evidence-based treatment is a strict gluten-free diet (GFD), which can readily lead to weight gain and unfavourable metabolic changes (eg, dyslipidaemia, fatty liver disease and insulin resistance) if followed without adequate dietary control. That can lead to increased cardiovascular risk (CV). We planned a randomised controlled trial to test the effect of a group-based, structured, 1-year, advanced dietary education, per the proposal of a Mediterranean diet vs standard of care, regarding the most relevant CV risk factors (eg, metabolic parameters and body composition) in CD patients. METHODS AND ANALYSIS: Randomisation will occur after the baseline dietary education and interview in a 1:1 allocation ratio. Outcomes include anthropometric parameters (body composition analysis including weight, Body Mass Index, fat mass, per cent body fat, skeletal muscle mass, visceral fat area and total body water) and CV risk-related metabolic parameters (eg, lipid profile, homocysteine, fasting glucose, haemoglobin A1c, Homeostatic Model Assessment Index, metabolic hormones, waist circumference, blood pressure, liver function tests, liver steatosis rate and diet composition). In this study, we aim to draw attention to a new aspect regarding managing CD: dietary education can lead to a better quality of the GFD, thereby reducing the risk of potential metabolic and CV complications. ETHICS AND DISSEMINATION: The study was approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (27521-5/2022/EÜIG). Findings will be disseminated at research conferences and in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05530070.

Indexed as

Body CompositionCardiovascular DiseasesCeliac DiseaseHeart Disease Risk FactorsRandomized Controlled Trials as TopicDiet, Gluten-FreeDiet, MediterraneanHumansMaleMulticenter Studies as TopicClinical TrialCoeliac diseaseHealth EducationNUTRITION & DIETETICSRandomized Controlled TrialRisk management

Identifiers

PMID39384235
PMCPMC11474741

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.