Implanted Closed-Loop Gastric Electrical Stimulation (CLGES) System with Sensor-Based Feedback Safely Limits Weight Regain at 24 Months
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Weight regain following bariatric surgery is not uncommon. Safe, effective weight loss treatment up to 1 year has been reported with the closed-loop gastric electrical stimulation (CLGES) system. Continuous recording of eating and activity behavior by onboard sensors is one of the novel features of this closed-loop electrical stimulation therapy, and may provide improved long-term weight maintenance by enhancing aftercare.
Four centers participating in a 12-month prospective multicenter randomized study monitored all implanted participants (n = 47) up to 24 months after laparoscopic implantation of a CLGES system. Weight loss, safety, quality of life (QOL), and cardiac risk factors were analyzed.
Weight regain was limited in the 35 (74%) participants remaining enrolled at 24 months. Mean percent total body weight loss (%TBWL) changed by only 1.5% between 12 and 24 months, reported at 14.8% (95% CI 12.3 to 17.3) and 13.3% (95% CI 10.7 to 15.8), respectively. The only serious device-/procedure-related adverse events were two elective system replacements due to lead failure in the first 12 months, while improvements in QOL and cardiovascular risk factors were stable thru 24 months.
During the 24 month follow-up, CLGES was shown to limit weight regain with strong safety outcomes, including no serious adverse events in the second year. We hypothesize that CLGES and objective sensor-based behavior data combined to produce behavior change. The study supports CLGES as a safe obesity treatment with potential for long-term health benefits.
ClinicalTrials.gov identifier: NCT01448785
KeywordsObesity Morbid obesity Gastric stimulation Eating behavior Weight loss
We would like to acknowledge the following investigators and site personnel who participated in the study: Investigators are as follows: Spain—Salvador Morales Conde, MD, Isaías Alarcón del Agua MD, Hospital Virgen del Rocio, Sevilla; Antonio José Torres, MD, Andrés Sanchez Pernaute, MD, Miguel A. Rubio, MD, Complutense University of Madrid Hospital Clinico “San Carlos”, Madrid; Antonio José Torres, Fernando Lapuente, Felipe Acedo, Antonio Picardo, Hospital Universitario Madrid Monteprincipe, Madrid. Italy—Franco Favretti, MD, Vicenza Regional Hospital, Vicenza; Giuseppe M. Rovera MD, San Luca Torino, Torino; Marco Anselmino MD, University Hospital Pisa, Pisa.
We would also like to thank sponsor personnel Javier Sanchez and Ksenija Mlinar for the support with device programming and data collection.
Compliance with Ethical Standards
Informed consent was obtained from all individual participants included in the study.
The study was conducted in accordance with Good Clinical Practice and consistent with the Declaration of Helsinki.
Conflict of Interest
Authors 1, 2, 4, 5, 6, 7, and 8 have nothing to disclose. Author 3 reports personal fees from IntraPace Inc., during the conduct of the study; and personal fees from Novo Nordisk, outside the submitted work. Authors 9 and 10 report personal fees from IntraPace Inc., during the conduct of the study.
- 4.Mechanick JI, Kushner RF, Sugerman HJ, et al. American Association of Clinical Endocrinologists, the Obesity Society, and American Society for Metabolic & bariatric surgery medical guidelines for clinical practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient. Surg Obes Relat Dis. 2008;4(5 Suppl):S109–84. https://doi.org/10.1016/j.soard.2008.08.009.CrossRefPubMedGoogle Scholar
- 5.Burke LE, Wang J, Sevick MA: Self-monitoring in weight loss: a systematic review of the literature. J Am Diet Assoc 2011, 111(1):92–102, 1, DOI: https://doi.org/10.1016/j.jada.2010.10.008.
- 6.Horbach T, Meyer G, Morales-Conde S, Alarcón del Agua I, Favretti F, Anselmino M, Rovera G, Dargent J, Stroh C, Susewind M et al: Multicenter randomized study of closed-loop gastric electrical stimulation versus laparoscopic adjustable gastric band for the treatment of obesity. Int J Obes 2016, 40 (12):1891–1898, DOI: https://doi.org/10.1038/ijo.2016.159.
- 7.Stunkard A, Messick S. Eating inventory: manual. San Antonio, TX: Pearson Education, Inc.; 1988.Google Scholar
- 9.Gillett MJ: International expert committee report on the role of the A1c assay in the diagnosis of diabetes: Diabetes Care 2009; 32(7): 1327-1334. The Clinical biochemist Reviews 2009, 30(4):197–200.Google Scholar
- 11.Allergan: Summary of safety and effectiveness, LAP-BAND® Adjustable Banding system In.; 2010.Google Scholar
- 12.Ethicon Endo-Surgery I: Summary of safety and effectiveness data, REALIZE adjustable gastric band. In.; 2007.Google Scholar