A novel intragastric balloon for treatment of obesity and type 2 diabetes. A two-center pilot trial
AuthorTønnesen, Christer Julseth; Hjelmesæth, Jøran Sture; Hofsø, Dag; Tonstad, Serena; Hertel, Jens Kristoffer; Heggen, Eli; Johnson, Line Kristin; Mathisen, Tor Erik; Kalager, Mette; Wieszczy, Paulina; Medhus, Asle Wilhelm; Løberg, Magnus; Aabakken, Lars; Bretthauer, Michael
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.