Evidence map›Paper›PMID 33597157›Full record

Trial reportGut2022

Safety and efficacy of hydrothermal duodenal mucosal resurfacing in patients with type 2 diabetes: the randomised, double-blind, sham-controlled, multicentre REVITA-2 feasibility trial.

Geltrude Mingrone, Annieke Cg van Baar, Jacques Devière, David Hopkins, Eduardo Moura, Cintia Cercato, Harith Rajagopalan, Juan Carlos Lopez-Talavera, Kelly White, Vijeta Bhambhani and 16 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Gut, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02879383 (Evaluation of the Effect of Duodenal Mucosal Resurfacing), which is not on this map. Cited by 55 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 2 pooled it
10.5field-weighted citation impact, top 1% of its field
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.

NCT02879383 nacompletednot on this map

Evaluation of the Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)

TypeinterventionalSponsorFractyl Health Inc.Ran2017 to 2019Enrolled109ConditionsDiabetes Mellitus, Type 2, Noninsulin-Dependent Diabetes MellitusArmsDMR Procedure, Sham Procedure
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 2 syntheses or guidelines pooled it, 106 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Endoscopic small bowel therapies for type 2 diabetes.Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition · 2026
    Review
  5. Article
  6. Endoscopy for Metabolic Diseases.Journal of clinical medicine · 2026
    Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Article
  12. A moonshot for diabetes and obesity.iGIE : innovation, investigation and insights · 2025
    Article
  13. Endoscopic bariatrics: Current status and emerging technologies.World journal of gastrointestinal endoscopy · 2025
    Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. Article
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

26 authors at 16 institutions in 8 countries.

Geltrude MingroneDivision of Obesity and Metabolic Diseases, Fondazione Policlinico Universitario A. Gemelli IRCCS-Università Cattolica del Sacro Cuore, Rome, Italy geltrude.mingrone@unicatt.it.ORCID 0000-0003-2021-528X
Annieke Cg van BaarDepartments of Gastroenterology and Hepatology, Academic Medical Center Amsterdam, Amsterdam, The Netherlands.
Jacques DevièreDepartment of Gastroenterology, Erasme University Hospital, Brussels, Belgium.
David HopkinsInstitute of Diabetes, Endocrinology and Obesity, King's Health Partners, London, UK.
Eduardo MouraDepartment of Gastroenterology, Universidade de Sao Paulo Medical School, Sao Paulo, Brazil.
Cintia CercatoObesity Unit, Department of Endocrinology, Hospital das Clínicas, University of Sao Paulo, Sao Paulo, Brazil.
Harith RajagopalanResearch and Development, Fractyl Laboratories, Inc, Lexington, Massachusetts, USA.
Juan Carlos Lopez-TalaveraResearch and Development, Fractyl Laboratories, Inc, Lexington, Massachusetts, USA.
Kelly WhiteResearch and Development, Fractyl Laboratories, Inc, Lexington, Massachusetts, USA.
Vijeta BhambhaniResearch and Development, Fractyl Laboratories, Inc, Lexington, Massachusetts, USA.
Guido CostamagnaDigestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS-Università Cattolica del Sacro Cuore, Rome, Italy.
Rehan HaidryDepartment of Gastroenterology, King's College Hospital, London, UK.
Eduardo GreccoDepartment of Surgery, ABC University, Medical School, São Paulo, Brazil.
Manoel Galvao NetoDepartment of Surgery, ABC University, Medical School, São Paulo, Brazil.
Guruprasad AithalNIHR Nottingham Biomedical Research Centre, Ottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, UK.ORCID 0000-0003-3924-4830
Alessandro RepiciHumanitas Clinical and Research Center - IRCCS, Rozzano, Italy.
Bu'Hussain HayeeDepartment of Gastroenterology, King's College Hospital, London, UK.ORCID 0000-0003-1670-8815
Amyn HajiKing's Institute of Therapeutic Endoscopy, King's College Hospital, London, UK.ORCID 0000-0002-6508-6488
A John MorrisDepartment of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.
Raf BisschopsGastroenterology Department, University of Leuven, Leuven, Belgium.ORCID 0000-0002-9994-8226
Manil D ChouhanDivision of Medicine, University College London Center for Medical Imaging, London, UK.
Naomi S SakaiDivision of Medicine, University College London Center for Medical Imaging, London, UK.
Deepak L BhattDivision of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Arun J SanyalDivision of Gastroenterology, Hepatology and Nutrition, Department of Internal Medicine, Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA.
J J G H M BergmanDepartments of Gastroenterology and Hepatology, Academic Medical Center Amsterdam, Amsterdam, The Netherlands.ORCID 0000-0001-7548-6955
Investigators of the REVITA-2 Study
Fractyl (United States) · USAmsterdam UMC Location University of Amsterdam · NLDiabetes Australia · AUFundação do ABC · BRKing's College Hospital · GBUniversità Cattolica del Sacro Cuore · ITUniversity College London · GBBrigham and Women's Hospital · USErasmus Hospital · BEGlasgow Royal Infirmary · GBHumanitas University · ITNottingham University Hospitals NHS Trust · GBThe King's College · USUniversidade de São Paulo · BRUniversity Gastroenterology · USVirginia Commonwealth University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveHydrothermal duodenal mucosal resurfacing (DMR) is a safe, outpatient endoscopic procedure. REVITA-2, a double-blind, superiority randomised controlled trial, investigates safety and efficacy of DMR using the single catheter Revita system (Revita DMR (catheter and system)), on glycaemic control and liver fat content in type 2 diabetes (T2D).

designEligible patients (haemoglobin A1c (HbA1c) 59-86 mmol/mol, body mass index≥24 and ≤40 kg/m

resultsOverall mITT (DMR n=56; sham n=52), 24 weeks post DMR, median (IQR) HbA1c change was -10.4 (18.6) mmol/mol in DMR group versus -7.1 (16.4) mmol/mol in sham group (p=0.147). In patients with baseline liver MRI-PDFF >5% (DMR n=48; sham n=43), 12-week post-DMR liver-fat change was -5.4 (5.6)% in DMR group versus -2.9 (6.2)% in sham group (p=0.096). Results from prespecified interaction testing and clinical parameter assessment showed heterogeneity between European (DMR n=39; sham n=37) and Brazilian (DMR n=17; sham n=16) populations (p=0.063); therefore, results were stratified by region. In European mITT, 24 weeks post DMR, median (IQR) HbA1c change was -6.6 mmol/mol (17.5 mmol/mol) versus -3.3 mmol/mol (10.9 mmol/mol) post-sham (p=0.033); 12-week post-DMR liver-fat change was -5.4% (6.1%) versus -2.2% (4.3%) post-sham (p=0.035). Brazilian mITT results trended towards DMR benefit in HbA1c, but not liver fat, in context of a large sham effect. In overall PP, patients with high baseline fasting plasma glucose ((FPG)≥10 mmol/L) had significantly greater reductions in HbA1c post-DMR versus sham (p=0.002). Most adverse events were mild and transient.

conclusionsDMR is safe and exerts beneficial disease-modifying metabolic effects in T2D with or without non-alcoholic liver disease, particularly in patients with high FPG. TRIAL REGISTRATION NUMBER: NCT02879383.

Indexed as

Catheter AblationEndoscopic Mucosal ResectionHyperthermia, InducedAdultAgedDiabetes Mellitus, Type 2Double-Blind MethodDuodenumFeasibility StudiesFemaleGlycated HemoglobinHumansIntestinal MucosaMaleMiddle AgedTreatment OutcomeGlycated Hemoglobinhemoglobin A1c protein, humandiabetes mellitusduodenal mucosaendoscopic proceduresfatty liver

Identifiers

PMID33597157
PMCPMC8761999
OpenAlexW3131132851

What OpenQuestion holds

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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 OpenQuestion graph.