• Gastrointest. Endosc. · May 2010

    Clinical Trial

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

    • Rosario Forlano, Antonio Massimo Ippolito, Angelo Iacobellis, Antonio Merla, Maria Rosa Valvano, Grazia Niro, Vito Annese, and Angelo Andriulli.
    • Division of Gastroenterology and Endoscopic Unit, Casa Sollievo della Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Italy.
    • Gastrointest. Endosc. 2010 May 1; 71 (6): 927-33.

    BackgroundIn 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.ObjectiveTo evaluate the effectiveness of BIB insertion on weight control and amelioration of components of the metabolic syndrome.DesignA 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.SettingDivision of Gastroenterology and Endoscopic Unit, "Casa Sollievo della Sofferenza" Hospital.PatientsOne 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).InterventionsPositioning of BIB.Main Outcome MeasurementsAnthropometric and laboratory parameters.ResultsOverall, 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 > or = 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.LimitationsNo sham-treated patients were included as comparative controls.ConclusionsTreatment was effective in inducing weight loss, improving liver steatosis, and restoring some components of the metabolic syndrome.2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

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