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dc.contributor.authorTønnesen, Christer Julseth
dc.contributor.authorHjelmesæth, Jøran Sture
dc.contributor.authorHofsø, Dag
dc.contributor.authorTonstad, Serena
dc.contributor.authorHertel, Jens Kristoffer
dc.contributor.authorHeggen, Eli
dc.contributor.authorJohnson, Line Kristin
dc.contributor.authorMathisen, Tor Erik
dc.contributor.authorKalager, Mette
dc.contributor.authorWieszczy, Paulina
dc.contributor.authorMedhus, Asle Wilhelm
dc.contributor.authorLøberg, Magnus
dc.contributor.authorAabakken, Lars
dc.contributor.authorBretthauer, Michael
dc.date.accessioned2021-11-23T09:37:22Z
dc.date.available2021-11-23T09:37:22Z
dc.date.issued2021-10-29
dc.description.abstractBackground and aims: Obesity with type-2 diabetes is a global challenge. Lifestyle interventions have limited effect for most patients. Bariatric surgery is highly effective, but resource-demanding, invasive and associated with serious complications. Recently, a new intragastric balloon was introduced, not requiring endoscopy for placement or removal (Elipse™, Allurion Inc., Natick, MA). The balloon is swallowed in a capsule and filled with water once in the stomach. The balloon self-deflates after 4 months and is naturally excreted. The present trial investigated balloon feasibility, safety and efficacy in patients with obesity and type-2 diabetes. <p> <p>Patients and methods: We treated 19 patients, with type-2 diabetes and body mass index (BMI) of 30.0-39.9 kg/m2 at two Norwegian centers with the Elipse balloon. Patient follow-up during balloon treatment mimicked real-world clinical practice, including dietary plan and outpatient visits. The primary efficacy endpoints were total body weight loss (TBWL) and HbA1c at weeks 16 and 52. <p> <p>Results: All patients underwent balloon insertion uneventfully as out-patients. Mean TBWL and HbA1c reduction after 16 and 52 weeks of balloon insertion was 3.9% (95%CI 2.1-5.7) and 0.8% (95%CI 1.9-3.5); and 7 (95%CI 4-10), and 1 (95%CI -6 to 9) mmol/mol, respectively. Adverse events occurred in two patients (10.5%): one developed gastric outlet obstruction, managed by endoscopic balloon removal; the other excessive vomiting and dehydration, managed conservatively. <p> <p>Conclusions: This first Scandinavian real-world clinical trial with a new minimally invasive intragastric balloon system demonstrated good feasibility, but did not confirm expected efficacy for weight loss and diabetes control.en_US
dc.identifier.citationTønnesen CJ, Hjelmesæth J, Hofsø D, Tonstad S, Hertel J, Heggen E, Johnson LK, Mathisen TE, Kalager M, Wieszczy P, Medhus AW, Løberg M, Aabakken L, Bretthauer M. A novel intragastric balloon for treatment of obesity and type 2 diabetes. A two-center pilot trial. Scandinavian Journal of Gastroenterology. 2021
dc.identifier.cristinIDFRIDAID 1952155
dc.identifier.doi10.1080/00365521.2021.1994641
dc.identifier.issn0036-5521
dc.identifier.issn1502-7708
dc.identifier.urihttps://hdl.handle.net/10037/23125
dc.language.isoengen_US
dc.publisherTaylor & Francisen_US
dc.relation.journalScandinavian Journal of Gastroenterology
dc.rights.holderCopyright 2021 The Author(s)en_US
dc.subjectVDP::Medical disciplines: 700::Basic medical, dental and veterinary science disciplines: 710en_US
dc.subjectVDP::Medisinske Fag: 700::Basale medisinske, odontologiske og veterinærmedisinske fag: 710en_US
dc.titleA novel intragastric balloon for treatment of obesity and type 2 diabetes. A two-center pilot trialen_US
dc.type.versionpublishedVersionen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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