PMID- 31331994
OWN - NLM
STAT- MEDLINE
DCOM- 20200129
LR  - 20221207
IS  - 1468-3288 (Electronic)
IS  - 0017-5749 (Print)
IS  - 0017-5749 (Linking)
VI  - 69
IP  - 2
DP  - 2020 Feb
TI  - Endoscopic duodenal mucosal resurfacing for the treatment of type 2 diabetes 
      mellitus: one year results from the first international, open-label, prospective, 
      multicentre study.
PG  - 295-303
LID - 10.1136/gutjnl-2019-318349 [doi]
AB  - BACKGROUND: The duodenum has become a metabolic treatment target through 
      bariatric surgery learnings and the specific observation that bypassing, 
      excluding or altering duodenal nutrient exposure elicits favourable metabolic 
      changes. Duodenal mucosal resurfacing (DMR) is a novel endoscopic procedure that 
      has been shown to improve glycaemic control in people with type 2 diabetes 
      mellitus (T2D) irrespective of body mass index (BMI) changes. DMR involves 
      catheter-based circumferential mucosal lifting followed by hydrothermal ablation 
      of duodenal mucosa. This multicentre study evaluates safety and feasibility of 
      DMR and its effect on glycaemia at 24 weeks and 12 months. METHODS: International 
      multicentre, open-label study. Patients (BMI 24-40) with T2D (HbA1c 
      59-86 mmol/mol (7.5%-10.0%)) on stable oral glucose-lowering medication underwent 
      DMR. Glucose-lowering medication was kept stable for at least 24 weeks post DMR. 
      During follow-up, HbA1c, fasting plasma glucose (FPG), weight, hepatic 
      transaminases, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), 
      adverse events (AEs) and treatment satisfaction were determined and analysed 
      using repeated measures analysis of variance with Bonferroni correction. RESULTS: 
      Forty-six patients were included of whom 37 (80%) underwent complete DMR and 36 
      were finally analysed; in remaining patients, mainly technical issues were 
      observed. Twenty-four patients had at least one AE (52%) related to DMR. Of 
      these, 81% were mild. One SAE and no unanticipated AEs were reported. 
      Twenty-four weeks post DMR (n=36), HbA1c (-10+/-2 mmol/mol (-0.9%+/-0.2%), p<0.001), 
      FPG (-1.7+/-0.5 mmol/L, p<0.001) and HOMA-IR improved (-2.9+/-1.1, p<0.001), weight 
      was modestly reduced (-2.5+/-0.6 kg, p<0.001) and hepatic transaminase levels 
      decreased. Effects were sustained at 12 months. Change in HbA1c did not correlate 
      with modest weight loss. Diabetes treatment satisfaction scores improved 
      significantly. CONCLUSIONS: In this multicentre study, DMR was found to be a 
      feasible and safe endoscopic procedure that elicited durable glycaemic 
      improvement in suboptimally controlled T2D patients using oral glucose-lowering 
      medication irrespective of weight loss. Effects on the liver are examined 
      further. TRIAL REGISTRATION NUMBER: NCT02413567.
CI  - (c) Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - van Baar, Annieke C G
AU  - van Baar ACG
AD  - Gastroenterology and Hepatology, Amsterdam University Medical Centers, location 
      Academic Medical Center, Amsterdam, The Netherlands.
FAU - Holleman, Frits
AU  - Holleman F
AD  - Internal Medicine, Amsterdam University Medical Centers, location Academic 
      Medical Center, Amsterdam, The Netherlands.
FAU - Crenier, Laurent
AU  - Crenier L
AD  - Endocrinology, Erasme University Hospital, Brussels, Belgium.
FAU - Haidry, Rehan
AU  - Haidry R
AD  - Gastroenterology, University College Hospital, London, UK.
FAU - Magee, Cormac
AU  - Magee C
AD  - Centre for Obesity Research, Department of Medicine, University College Hospital, 
      London, UK.
FAU - Hopkins, David
AU  - Hopkins D
AD  - Institute of Diabetes, Endocrinology and Obesity, King's Health Partners, London, 
      UK.
FAU - Rodriguez Grunert, Leonardo
AU  - Rodriguez Grunert L
AD  - CCO Clinical Center for Diabetes, Obesity and Reflux, Santiago, Chile.
FAU - Galvao Neto, Manoel
AU  - Galvao Neto M
AD  - Bariatric Endoscopy Service, Gastro Obeso Center, Sao Paulo, Brazil.
AD  - College of Medicine, Florida International University, Miami, Florida, USA.
FAU - Vignolo, Paulina
AU  - Vignolo P
AD  - CCO Clinical Center for Diabetes, Obesity and Reflux, Santiago, Chile.
FAU - Hayee, Bu'Hussain
AU  - Hayee B
AD  - Gastroenterology, King's College Hospital, London, UK.
FAU - Mertens, Ann
AU  - Mertens A
AD  - Clinical and Experimental Endocrinology, Catholic University of Leuven, Leuven, 
      Belgium.
FAU - Bisschops, Raf
AU  - Bisschops R
AD  - Gastroenterology and Hepatology, Catholic University of Leuven, Leuven, Belgium.
FAU - Tijssen, Jan
AU  - Tijssen J
AD  - Cardiology, Amsterdam University Medical Centers, location AMC, Amsterdam, The 
      Netherlands.
FAU - Nieuwdorp, Max
AU  - Nieuwdorp M
AD  - Internal and Vascular Medicine, Amsterdam University Medical Centers, location 
      AMC, Amsterdam, The Netherlands.
FAU - Guidone, Caterina
AU  - Guidone C
AD  - Internal Medicine, Fondazione Policlinico A. Gemelli IRCSS, Rome, Italy.
FAU - Costamagna, Guido
AU  - Costamagna G
AD  - Digestive Endoscopy Unit, Catholic University, Gemelli University Hospital, Roma, 
      Italy.
FAU - Deviere, Jacques
AU  - Deviere J
AD  - Gastroenterology, Erasme University Hospital, Brussels, Belgium.
FAU - Bergman, Jacques J G H M
AU  - Bergman JJGHM
AUID- ORCID: 0000-0002-2283-5098
AD  - Gastroenterology and Hepatology, Amsterdam University Medical Centers, location 
      Academic Medical Center, Amsterdam, The Netherlands.
LA  - eng
SI  - ClinicalTrials.gov/NCT02413567
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20190722
PL  - England
TA  - Gut
JT  - Gut
JID - 2985108R
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (hemoglobin A1c protein, human)
SB  - IM
CIN - Gut. 2020 Dec;69(12):2260-2261. PMID: 32102927
CIN - Gut. 2021 Jan;70(1):218. PMID: 32229545
MH  - Adult
MH  - Aged
MH  - Blood Glucose/metabolism
MH  - Diabetes Mellitus, Type 2/blood/drug therapy/*surgery
MH  - Duodenoscopy/*methods
MH  - Duodenum/*surgery
MH  - Endoscopic Mucosal Resection/adverse effects/*methods
MH  - Feasibility Studies
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/therapeutic use
MH  - Intestinal Mucosa/*surgery
MH  - Male
MH  - Middle Aged
MH  - Patient Satisfaction
MH  - Prospective Studies
PMC - PMC6984054
OTO - NOTNLM
OT  - diabetes mellitus
OT  - duodenal mucosa
OT  - endoscopic procedures
OT  - glucose metabolism
OT  - therapeutic endoscopy
COIS- Competing interests: FH reports speaker fees from Sanofi, Bioton and Astra 
      Zeneca. DH reports consultancy for Novo Nordisk, Sanofi and Roche and speaker 
      fees from Novo Nordisk, Sanofi, Roche, Astra Zeneca, Boerhinger, Napp, Medtronic, 
      Sunovion and Fractyl Laboratories. LRG reports consultancy for Fractyl 
      Laboratories. MGN reports consultancy for Fractyl Laboratories, GI Dynamics, GI 
      Windows, Ethicon EndoSurgery, Meditronics, Apollo EndoSurgery, Consultant and 
      Scientific Advisory Board member for GI Dynamics and Faculty in training courses 
      for Ethicon EndoSurgery and Meditronics.
EDAT- 2019/07/25 06:00
MHDA- 2020/01/30 06:00
PMCR- 2020/01/27
CRDT- 2019/07/24 06:00
PHST- 2019/01/23 00:00 [received]
PHST- 2019/06/19 00:00 [revised]
PHST- 2019/06/30 00:00 [accepted]
PHST- 2019/07/25 06:00 [pubmed]
PHST- 2020/01/30 06:00 [medline]
PHST- 2019/07/24 06:00 [entrez]
PHST- 2020/01/27 00:00 [pmc-release]
AID - gutjnl-2019-318349 [pii]
AID - 10.1136/gutjnl-2019-318349 [doi]
PST - ppublish
SO  - Gut. 2020 Feb;69(2):295-303. doi: 10.1136/gutjnl-2019-318349. Epub 2019 Jul 22.