Implantable gastric stimulation for the treatment of clinically severe obesity: results of the SHAPE trial

{ "0" : "Tufts Medical Center, Boston, Massachusetts" , "1" : "International Diabetes Center at Park Nicollet, Minneapolis, Minnesota" , "2" : "Columbia-Presbyterian Medical Center, New York, New York" , "3" : "George Washington University, Washington, DC" , "4" : "Temple University, Philadelphia, Pennsylvania" , "5" : "University of Florida College of Medicine, Gainesville, Florida" , "6" : "Washington University, St. Louis, Missouri" , "7" : "Northwestern Memorial Hospital, Chicago, Illinois" , "8" : "University of Pennsylvania, Philadelphia, Pennsylvania" , "10" : "Morbid obesity" , "11" : "Severe obesity" , "12" : "Implantable gastric stimulation" , "13" : "Weight loss" , "14" : "Bariatric surgery" , "15" : "Gastric pacing"}
Surgery for Obesity and Related Diseases (Impact Factor: 4.94). 01/2009; DOI: 10.1016/j.soard.2008.09.012

ABSTRACT BackgroundTo compare implantable gastric stimulation therapy with a standard diet and behavioral therapy regimen in a group of carefully selected class 2 and 3 obese subjects by evaluating the difference in the percentage of excess weight loss (EWL) between the control and treatment groups. The primary endpoint was the percentage of EWL from baseline to 12 months after randomization. Implantable gastric stimulation has been proposed as a first-line treatment for severely obese patients; however, previous investigations have reported inconclusive results.MethodsA total of 190 subjects were enrolled in this prospective, randomized, placebo-controlled, double-blind, multicenter study. All patients underwent implantation with the implantable gastric stimulator and were randomized to 1 of 2 treatment groups: the control group (stimulation off) or treatment group (stimulation on). The patients were evaluated on a monthly basis. All individuals who enrolled in this study agreed to consume a diet with a 500-kcal/d deficit and to participate in monthly support group meetings.ResultsThe procedure resulted in no deaths and a low complication rate. The primary endpoint of a difference in weight loss between the treatment and control groups was not met. The control group lost 11.7% ± 16.9% of excess weight and the treatment group lost 11.8% ± 17.6% (P = .717) according to an intent-to-treat analysis.ConclusionImplantable gastric stimulation as a surgical option for the treatment of morbid obesity is a less complex procedure than current bariatric operations. However, the results of the present study do not support its application. Additional research is indicated to understand the physiology and potential benefits of this therapy.

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    ABSTRACT: Background We report our initial gastric electrical stimulation experience using the abiliti® system for the treatment of obese patients followed for 1 year. Method Between March 2011 and June 2013, 27 obese patients (BMI 30 to 46 kg/m2) were enrolled in a prospective open label study and implanted with a gastric stimulator. The patients were provided with nutritional support, and sensor-based behavioral feedback. Results At 12 months, percent excess weight loss (%EWL) obtained was 49.3 ± 19.2 % with no significant differences between gender or age sub-groups. The %EWL data were segmented into two groups according to BMI 30–40 kg/m2 patients (obesity grade I and II) and BMI >40 kg/m2, with the results of weight loss being significantly higher for the lower BMI group (59.1 ± 19.5 vs. 46.7 ± 13.4, respectively, p < 0.01). One subject requested to have his device explanted, and the minor postoperative adverse events were resolved without hospital admission. All patients experienced early satiety and reduced their intake. Conclusions After 12 months of follow-up, gastric electrical stimulation treatment appears to be a safe and effective option for weight loss in obese subjects. Long-term follow-up and further studies are warranted.
    Obesity Surgery 11/2014; 25. DOI:10.1007/s11695-014-1498-1 · 3.74 Impact Factor
  • New Advances in Gastrointestinal Motility Research, Edited by L. K. Cheng, 01/2013: chapter Spatiotemporal mapping techniques for quantifying gut motility: pages 219-241; Dordrecht: Springer Science+Buisiness Media.
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    ABSTRACT: Mercury vapor poses a known health risk with no clearly established safe level of exposure. Consequently there is debate over whether the level of prolonged exposure to mercury vapor from dental amalgam fillings, combining approximately 50% mercury with other metals, is sufficiently high to represent a risk to health. The objective of our study is to determine if mercury exposure from amalgam fillings is associated with risk of adverse health effects. In a large longitudinal non-blind sample of participants from a preventative health program in Calgary, Canada we compared number of amalgam fillings, urine mercury measures and changes in 14 self-reported health symptoms, proposed to be mercury dependent sub-clinical measures of mental and physical health. The likelihood of change over one year in a sample of persons who had their fillings removed was compared to a sample of persons who had not had their fillings removed. We use non-parametric statistical tests to determine if differences in urine mercury were statistically significant between sample groups. Logistic regression models were used to estimate the likelihood of observing symptom improvement or worsening in the sample groups. At baseline, individuals with dental amalgam fillings have double the measured urine mercury compared to a control group of persons who have never had amalgam fillings. Removal of amalgam fillings decreases measured urine mercury to levels in persons without amalgam fillings. Although urine mercury levels in our sample are considered by Health Canada to be too low to pose health risks, removal of amalgam fillings reduced the likelihood of self-reported symptom deterioration and increased the likelihood of symptom improvement in comparison to people who retained their amalgam fillings. Our findings suggest that mercury exposure from amalgam fillings adversely impact health and therefore are a health risk. The use of safer alternative materials for dental fillings should be encouraged to avoid the increased risk of health deterioration associated with unnecessary exposure to mercury.
    Environmental Health 11/2014; 13(1):95. DOI:10.1186/1476-069X-13-95 · 2.71 Impact Factor