Implantable gastric stimulation for the treatment of clinically severe obesity: results of the SHAPE trial. Surg Obes Relat Dis 5:31

{ "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: 4.07). 02/2009; 5(1):31-37. DOI: 10.1016/j.soard.2008.09.012


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.

36 Reads
  • Source
    • "A study followed up 69 European obese patients and reported significant reductions in weight by GES [24]. However, in some studies, a loss in excess body weight was not observed [25–27]. A clinical trial with 103 patients in the USA reported no greater weight loss at 7 months in those with the device activated compared with those with sham stimulation [27]. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Gastric electrical stimulation (GES) has been proposed as a promising therapeutic option in treating obesity for 20 years. Currently, the available device of GES cannot meet the clinical needs. The purpose of this study is to verify the effect of a new type of adjustable gastric electrical stimulator in reducing food intake and body weight. Eight beagle dogs randomly followed GES and sham GES for 3 months in a crossover design. Parameters were adjusted and individualized during the experiment. Symptoms of GES were recorded, and the effective parameters were selected. Resistance to GES was assessed. Food intake and body weight were measured to evaluate the effect of GES. The effective parameters were varied among the dogs. Resistance to GES was observed in different periods in dogs. Parameters needed to be adjusted every 10.2 ± 2.1 days during the period of GES. Food intake during GES for 3 months was significantly reduced than that during sham GES of 3 months (P < 0.05). With the decreased food intake, body weight was significantly reduced by the end of GES of 3 months compared with that of sham GES of 3 months (P < 0.05). Food intake and body weight of dogs are significantly reduced by adjustable GES. Individual parameters and resistance during GES are required to be considered. The new adjustable device may have good prospects of clinical application for obesity.
    Obesity Surgery 07/2013; 24(1). DOI:10.1007/s11695-013-1037-5 · 3.75 Impact Factor
  • Source
    • "A single lead is laparoscopically implanted at the area of the lesser curvature, and a stimulating current is applied with the following parameters: pulse amplitude = 10.0 mA, pulse width = 208 microseconds, burst “on” time = 2 seconds, burst “off” time = 3 seconds, and a burst rate = 40 Hz. Several initial studies in Europe [137, 138] landed the technology the CE certification mark, but in December 2005 Medtronic announced that the preliminary results of their Screened Health Assessment and Pacer Evaluation (SHAPE) trial using the Transcend device did not meet the efficacy endpoint of a difference in mean excess weight loss at one year [139]. In the absence of slow wave entrainment manipulation and of direct production of circumferential contractions, the eventual mechanism of action has not been unequivocally, adequately, and reliably elucidated [38]. "
    [Show abstract] [Hide abstract]
    ABSTRACT: GROWING WORLDWIDE OBESITY EPIDEMIC HAS PROMPTED THE DEVELOPMENT OF TWO MAIN TREATMENT STREAMS: (a) conservative approaches and (b) invasive techniques. However, only invasive surgical methods have delivered significant and sustainable benefits. Therefore, contemporary research exploration has focused on the development of minimally invasive gastric manipulation methods featuring a safe but reliable and long-term sustainable weight loss effect similar to the one delivered by bariatric surgeries. This antiobesity approach is based on placing external devices in the stomach ranging from electrodes for gastric electrical stimulation to temporary intraluminal bezoars for gastric volume displacement for a predetermined amount of time. The present paper examines the evolution of these techniques from invasively implantable units to completely noninvasive patient-controllable implements, from a functional, rather than from the traditional, parametric point of view. Comparative discussion over the available pilot and clinical studies related to gastric electrical stimulation outlines the promises and the fallacies of this concept as a reliable alternative anti-obesity strategy.
    02/2013; 2013:434706. DOI:10.1155/2013/434706
  • Source
    • "Though many anti-obesity drugs have been developed few have been either highly effective or safe[19]. Both implanted gastric stimulators to mimic the stretch reflex[20] and ghrelin agonists (e.g. MK-677 to reduce visceral adiposity)[21] and ghrelin binders in mice (Speigelmers)[22] have failed to duplicate the effect of surgery. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Not too long ago surgeons routinely treated metabolic problems including hypertension, hyperlipidaemia and obesity. However, these areas declined as drug therapies became available and surgical approaches lost favour due to high rates of perceived complications. Surgery survived in specialist metabolic oncological applications for treatment of endocrine adenomas or carcinomas. Metabolic endocrine surgery has grown ever more sophisticated with better imaging, more sensitive sampling techniques, intra-operative endocrine monitoring using point-of-care assay technologies and the increasing use of minimal access and eventually robotic surgery techniques (1-3). The diagnosis of primary hyperparathyroidism (PHPT) is more frequently made at a significantly earlier stage than in the past. Surgery is performed for both prognostic benefit and symptom relief. Surgical approaches have evolved rapidly in recent years with an evolution in minimally invasive procedures aided by improvements in pre-operative localisation (4). Day surgery procedures are common and intra-operative assays of parathyroid hormone can be used to confirm surgical success in minutes. Type II calcimimetic drugs that enhance the sensitivity of the calcium-sensing receptor to calcium resulting in a decrease in PTH secretion are used in secondary hyperparathyroidism reducing the need for surgery in some patients (5), and may also have a selective role in complicated patients with PHPT and malignancy. In other areas surgery disappeared such as when initially H2 antagonists and later proton pump inhibitors (PPIs) replaced the need for gastric acid reduction by vagotomy.
    International Journal of Clinical Practice 07/2011; 65(7):728-32. DOI:10.1111/j.1742-1241.2011.02696.x · 2.57 Impact Factor
Show more