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

doi:10.1016/j.gie.2009.06.036

Gastrointestinal Endoscopy

Volume 71, Issue 6, May 2010, Pages 927-933

https://doi.org/10.1016/j.gie.2009.06.036 Get rights and content

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.

Section snippets

Patients

Obese patients were selected according to the National Institutes of Health criteria and guidelines for obesity surgery.⁷ Only patients without medical or psychological contraindications to BIB placement and who agreed to comply with the follow-up investigations were enrolled.

According to BMI values, obesity was categorized as superobesity by a BMI of 50 kg/m² or higher, class III obesity by a BMI of 40 to 49.9 kg/m² or higher, class II by a BMI of 35 kg/m² or higher but 39.9 kg/m² or lower

Methods

The endoscopist examined all patients and explained in detail the BIB procedure. Informed written consent was obtained from all patients, and the study was conducted in conformity with the Declaration of Helsinki.

All patients were hospitalized. With the patients under anesthesia with propofol (2 mg/kg administered intravenously), a preliminary upper GI endoscopy was performed to exclude pathologic lesions. Thereafter, the balloon was passed into the gastric fundus and inflated with a saline

Baseline characteristics of patients

From January 2004 to July 2007, 130 obese patients were enrolled in a prospective study. The BIB was placed and removed endoscopically without associated complications. The mean (SD) time for BIB positioning was 14 (2) minutes (range 10-20 minutes). In the 48 hours after BIB insertion, 60% of patients reported nausea, vomiting, and mild abdominal pain, which was successfully managed by medical therapy in the majority of cases. Of the 130 patients, 10 (8%) required early balloon removal because

Discussion

A recent Cochrane review of 9 randomized, controlled trials on 395 obese patients found little benefit of intragastric balloon placement for weight loss.¹⁶ However, the intrinsic validity of this conclusion might be flawed by the great heterogeneity regarding both methodologic and clinical aspects in surveyed trials. By pooling data from 15 studies that used BIB, Imaz et al⁹ recently reported a pooled estimate for weight loss of 14.7 kg and a pooled BMI loss of 5.7 kg/m², and our results

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

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

Background

Objective

Design

Setting

Patients

Interventions

Main Outcome Measurements

Results

Limitations

Conclusions

Section snippets

Patients

Methods

Baseline characteristics of patients

Discussion

Physiol Behav

Gastrointest Endosc

Dig Liver Dis

Am J Med

Prevalence of overweight and obesity in the United States, 1999-2004

JAMA

Long-term weight control: the National Heart, Lung, Blood Institute funded multimodal intervention study

Clin Pharmacol

Long term pharmacotherapy for obesity and overweight: update and meta-analysis

Br Med J

Surgery for severe obesity

N Engl J Med

Effects of bariatric surgery on mortality in Swedish obese subjects

N Engl J Med

Gastrointestinal surgery for severe obesity. Consensus development conference panel

Ann Intern Med

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