A novel intragastric balloon for treatment of obesity and type 2 diabetes. A two-center pilot trial
| Autor: | Christer Julseth Tønnesen, Asle W. Medhus, Tor Erik Mathisen, Magnus Løberg, Michael Bretthauer, Dag Hofsø, Lars Aabakken, Paulina Wieszczy, Jens Kristoffer Hertel, Eli Heggen, Line Kristin Johnson, Mette Kalager, Jøran Hjelmesæth, Serena Tonstad |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Pilot Projects Type 2 diabetes Balloon Body Mass Index Weight loss Diabetes mellitus medicine Humans Obesity Adverse effect Gastric Balloon business.industry Gastroenterology Gastric outlet obstruction VDP::Medisinske Fag: 700::Basale medisinske odontologiske og veterinærmedisinske fag: 710 medicine.disease VDP::Medical disciplines: 700::Basic medical dental and veterinary science disciplines: 710 Surgery Obesity Morbid Clinical trial Treatment Outcome Diabetes Mellitus Type 2 Vomiting Feasibility Studies medicine.symptom business |
| ISSN: | 0036-5521 |
| Popis: | Background 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. 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. 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. 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. |
| Databáze: | OpenAIRE |
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