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

Rosario Forlano, MD, Antonio Massimo Ippolito, MD, Angelo Iacobellis, MD, Antonio Merla, MD, Maria Rosa Valvano, PhD, Grazia Niro, MD, Vito Annese, MD, Angelo Andriulli, MDCorresponding Author Information

Received 25 February 2009; accepted 25 June 2009. published online 28 October 2009.
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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/m2.

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/m2, 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/m2), the mean (SD) weight and BMI decreased by 16.4 (6.3) kg and 6.4 (2.3) kg/m2, 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.

Rotondo, Italy

Current affiliations: Division of Gastroenterology and Endoscopic Unit, “Casa Sollievo della Sofferenza” Hospital, IRCCS, San Giovanni Rotondo, Italy

Corresponding Author InformationReprint requests: Angelo Andriulli, MD, Division of Gastroenterology, “Casa Sollievo della Sofferenza” Hospital, IRCCS, viale Cappuccini 1, San Giovanni Rotondo, Italy.

 DISCLOSURE: The authors disclosed no financial relationships relevant to this publication.

PII: S0016-5107(09)02193-2

doi:10.1016/j.gie.2009.06.036