Effect of the BioEnterics intragastric balloon on weight, insulin resistance, and liver steatosis in obese patients

Background: In obese patients, positioning of the BioEnterics intragastric balloon (BIB) proved beneficial for weight loss, but the effect of the device on ameliorating some components of the metabolic syndrome associated with obesity remains uncertain. Objective: To evaluate the effectiveness of BIB insertion on weight control and amelioration of components of the metabolic syndrome. Design: A prospective intervention study performed at baseline, 6 months after BIB insertion, and after a mean (standard deviation [SD]) of 21 (3) months (range 14-26) of follow-up. Setting: Division of Gastroenterology and Endoscopic Unit, "Casa Sollievo della Sofferenza" Hospital. Patients: One hundred thirty obese patients with a mean (SD) weight of 118 (24) kg and mean (SD) body mass index (BMI) of 43 (8) kg/m(2). Interventions: Positioning of BIB. Main Outcome Measurements: Anthropometric and laboratory parameters. Results: Overall, the mean (SD) weight and BMI decreased by 13.2 (8.2) kg and 5.1 (3.2) kg/m(2), respectively, compared with baseline. The mean glycemia, insulinemia, Homeostasis Model Assessment index, triglyceridemia, and alanine aminotransferase levels were significantly reduced. In the 91 responders (BMI decrease of >= 3.5 kg/m(2)), the mean (SD) weight and BMI decreased by 16,4 (6.3) kg and 6.4 (2.3) kg/m(2), respectively, and severe liver steatosis decreased from 52% to 4% (P < .0001). On multivariate analysis, severe steatosis and the Homeostasis Model Assessment index were predictive of the response to BIB: odds ratios of 6.71 (95% CI, 2.23-20.19) and 3.18 (95% CI, 1.20-8.42). After a median follow-up of 22 months after BIB removal, 50% of responders maintained or continued to lose weight. Limitations: No sham-treated patients were included as comparative controls. Conclusions: Treatment was effective in inducing weight loss, improving liver steatosis, and restoring some components of the metabolic syndrome. (Gastrointest Endosc 2010;71:927-33.)