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MILEPOST Multicenter Randomized Controlled Trial: 12-Month Weight Loss and Satiety Outcomes After pose SM vs. Medical Therapy

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Abstract

Background

Pose SM is an endolumenal weight-loss intervention in which suture anchors are placed endoscopically in the gastric fundus/distal gastric body. Observational studies of pose have shown safe, effective weight loss. Twelve-month results of a randomized controlled trial comparing weight loss and satiety after pose vs. conventional medical therapy are reported.

Methods

Subjects with classes I–II obesity were randomized in a 3:1 ratio to pose or diet/exercise guidance only (control). Pose subjects received gastric fundus and distal body suture-anchor plications with diet/exercise counseling. Total body (%TBWL) and excess weight loss (%EWL) were assessed at 6 and 12 months. Analysis of covariance (ANCOVA) was used to analyze 12-month %TBWL. Satiety changes were assessed at 6 and 12 months.

Results

From November 2013 to July 2014, 44 subjects were randomized (34, 77.3 % female; mean age, 38.3 ± 10.7 years; body mass index, 36.5 ± 3.4 kg/m2) to pose (n = 34) or control (n = 10) groups in three centers. Mean pose procedure time was 51.8 ± 14.5 min; pose subjects received a mean 8.8 ± 1.3 fundal and 4.2 ± 0.7 distal body plications. Twelve-month TBWL: pose, 13.0 % (EWL, 45.0 %), n = 30 vs. control group, 5.3 % (18.1 %), n = 9; significant mean difference, 7.7 % (95 % CI 2.2, 13.2; p < 0.01). Pose subjects showed significant reductions in satiety parameters (p < 0.001); controls experienced reduced caloric intake and satiety volume (p < 0.05). No serious device- or procedure-related adverse events occurred.

Conclusions

In a randomized controlled trial at 12 months, pose-treated subjects had significantly greater weight loss than those treated with diet/exercise guidance alone. At 6 and 12 months, pose subjects showed significant reduction in satiety parameters.

Study registration: clinicaltrials.gov identifier # NCT01843231

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References

  1. World Health Organization. Obesity and overweight—fact sheet no. 312. Updated March 2013. http://www.who.int/mediacentre/factsheets/fs311/en/. Accessed 13 March 2015.

  2. Guh DP, Zhang W, Bansback N, Amarsi Z, Birmingham CL, Anis AH. The incidence of co-morbidities related to obesity and overweight: a systematic review and meta-analysis. BMC Public Health. 2009;9(1):88.

    Article  PubMed  PubMed Central  Google Scholar 

  3. Overweight and obesity. Center for Disease Control and Prevention website. www.cdc.gov/obesity/resources/factsheets.html. Accessed March 16, 2015.

  4. Aguilar-Valles A, Inoue W, Rummel C, Luheshi GN. Obesity, adipokines, and neuroinflammation. Neuropharmacology. 2015;96(Pt A):124–34 .Review

    Article  CAS  PubMed  Google Scholar 

  5. Hammond RA, Levine R. The economic impact of obesity in the United States. Diabetes Metab Syndr Obes. 2010;3:285–95.

    Article  PubMed  PubMed Central  Google Scholar 

  6. Cremieux PY, Buchwald H, Shikora SA, Ghosh A, Yang HE, Buessing M. A study on the economic impact of bariatric surgery. Am J Manag Care. 2008;14(9):589–96.

    PubMed  Google Scholar 

  7. Dee A, Kearns K, O'Neill C, Sharp L, Staines A, O'Dwyer V, et al. The direct and indirect costs of both overweight and obesity: a systematic review. BMC Res Notes 2014;7:242. Review.

  8. O’Brien PE, McPhail T, Chaston TB, et al. Systematic review of medium-term weight loss after bariatric operations. Obes Surg. 2006;16:1032–40.

    Article  PubMed  Google Scholar 

  9. Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, et al. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012;366(17):1567–76.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  10. Ribaric G, Buchwald JN, McGlennon TW. Diabetes and weight in comparative studies of bariatric surgery vs conventional medical therapy: a systematic review and meta-analysis. Obes Surg. 2014;24(3):437–55.

    Article  CAS  PubMed  Google Scholar 

  11. Buchwald H, Estok R, Fahrbach K, Banel D, Sledge I. Trends in mortality in bariatric surgery: a systematic review and meta-analysis. Surgery. 2007;142(4):621–32.

    Article  PubMed  Google Scholar 

  12. Nguyen NT, Morton JM, Wolfe BM, Schirmer B, Ali M, Traverso LW. The SAGES bariatric surgery outcome inititiave. Surg Endosc. 2005;19:1429–38.

    Article  CAS  PubMed  Google Scholar 

  13. Afonso BB, Rosenthal R, Li KM, Zapatier J, Szomstein S. Perceived barriers to bariatric surgery among morbidly obese patients. Surg Obes Relat Dis. 2010;6(1):16–21.

    Article  PubMed  Google Scholar 

  14. Gregory DM, Temple Newhook J, Twells LK. Patients’ perceptions of waiting for bariatric surgery: a qualitative study. Int J Equity Health. 2013;12:86.

    Article  PubMed  PubMed Central  Google Scholar 

  15. Padwal R, Chang H-J, Klarenbach S, Sharma A, Majumdar S. Characteristics of the population eligible for and receiving publicly funded bariatric surgery in Canada. Int J Equity Health. 2012;11:54.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Marmot M. Fair Society, Healthy Lives. The Marmot Review. Strategic review of health inequalities in England post-2010. Executive Summary. 2010. www.ucl.ac.uk/marmotreview.

  17. Mahony D. Bariatric surgery attrition secondary to psychological barriers. Clin Obes. 2013;3(1–2):32–8.

    Article  CAS  PubMed  Google Scholar 

  18. Treato.com. Treato finds 85 % of overweight consumers would not consider having bariatric surgery. PR Newswire. June 30, 2015: http://www.prnewswire.com/news-releases/treato-finds-85-of-overweight-consumers-would-not-consider-having-bariatric-surgery-510919661.html

  19. Martin M, Beekley A, Kjorstad R, Sebesta J. Socioeconomic disparities in eligibility and access to bariatric surgery: a national population-based analysis. Surg Obes Relat Dis. 2010;6(1):8–15.

    Article  PubMed  Google Scholar 

  20. ASMBS. http://asmbs.org/resources/emerging-technologies-and-procedures-inventory

  21. Verma R, Eid G, Ali M, Saber A, Pryor AD. ASMBS emerging technologies and procedures committee. Emerging technologies and procedures: results of an online survey and real-time poll. Surg Obes Relat Dis. 2015;11(1):161–8.

    Article  PubMed  Google Scholar 

  22. Espinós JC, Turró R, Mata A, Cruz M, da Costa M, Villa V, et al. Early experience with the incisionless operating platform™ (IOP) for the treatment of obesity: the primary obesity surgery endolumenal (pose) procedure. Obes Surg. 2013;23(9):1375–83.

    Article  PubMed  Google Scholar 

  23. López-Nava G, Bautistia-Castaño I, Jiminez A, de Grado T, Fernandez-Corbelle JP. The primary obesity surgery endolumenal (pose) procedure: one-year patient weight loss and safety outcomes. Surg Obes Relat Dis. 2015;11(4):861–5.

    Article  PubMed  Google Scholar 

  24. Espinós JC, Turró R, Moragas G, Bronstone A, Buchwald JN, Mearin F, et al. Gastrointestinal physiological changes and their relationship to weight loss following the pose procedure. Obes Surg. 2015.

  25. Protocol registration. Use of the Incisionless Operating Platform as a Primary Treatment for Obesity vs. Diet-Exercise Alone (MILEPOST). Clinical Trials Identifier NCT01843231. April 22, 2013. https://clinicaltrials.gov/ct2/show/NCT01843231?term=USGI&rank=6

  26. USGI Medical. Protocol: a randomized controlled multicenter study of an incisionless operating platform for primary obesity vs. diet-exercise alone: The MILEPOST study. 2014.

  27. Puigvehi M, Gras-Miralles B, Torra S, Alsina S, et al. Comparison of ad-libitum energy intake and the neuro-endocrine postprandial response as measured during a buffet-type meal and a standardized nutrient drink test. Gastroenterology. 2012;142:S-56.

  28. Meyer-Gerspach AC, Wölnerhanssen B, Beglinger B, Nessenius F, Napitupulu M, Schulte FH, et al. Gastric and intestinal satiation in obese and normal weight healthy people. Physiol Behav. 2014;129:265–71.

    Article  CAS  PubMed  Google Scholar 

  29. Torra S, Ilzarbe L, Malagelada JR, Negre M, Mestre-Fusco A, Aguade-Bruix S, et al. Meal size can be decreased in obese subjects through pharmacological acceleration of gastric emptying (the OBERYTH trial). Int J Obes. 2011;35(6):829–37.

    Article  CAS  Google Scholar 

  30. USGI Medical. Randomized controlled multicenter study of an incisionless operating platform for primary obesity vs. diet-exercise alone: the MILEPOST study. TPR41936 Rev F, 2014.

  31. Sjöström L. Review of the key results from the Swedish obese subjects (SOS) trial—a prospective controlled intervention study of bariatric surgery. J Intern Med. 2013;273(3):219–34.

    Article  PubMed  Google Scholar 

  32. Heo YS, Park JM, Kim YJ, et al. Bariatric surgery versus conventional therapy in obese Korea patients: a multicenter retrospective cohort study. J Korean Surg Soc. 2012;83(6):335–42.

    Article  PubMed  PubMed Central  Google Scholar 

  33. Shauer PR, Bhatt DL, Kirwan JP, Wolski K, Brethauer SA, Navaneethan SD. Bariatric surgery versus intensive medical therapy for diabetes—3-year outcomes. N Engl J Med. 2014;370(21):2002–13.

    Article  Google Scholar 

  34. Mingrone G, Panunzi S, De Gaetano A, Guidone C, Iaconelli A, Leccesi L, et al. Bariatric surgery versus conventional medical therapy for type 2 diabetes. N Engl J Med. 2012;366(17):1577–85.

    Article  CAS  PubMed  Google Scholar 

  35. Maggard-Gibbons M, Maglione M, Livhits M, Ewing B, Maher HR, Hu K, et al. Bariatric surgery for weight loss and glycemic control in nonmorbidly obese adults with diabetes: a systematic review. JAMA. 2013;309(21):2250–61.

    Article  CAS  PubMed  Google Scholar 

  36. Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev. 2014;8:CD003641 .Review

    Google Scholar 

  37. Padwal R, Klarenbach S, Wiebe N, Birch D, Karmali S, Manns B, et al. Bariatric surgery: a systematic review and network meta-analysis of randomized medical versus surgical treatment of type 2 diabetes: the search for level 1 evidence. Obes Rev. 2011;12:602–21.

    Article  CAS  PubMed  Google Scholar 

  38. Buchwald H, Avidor Y, Braunwald E, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004;292(14):1724–37.

    Article  CAS  PubMed  Google Scholar 

  39. Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, et al. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009;122(3):248–56.

    Article  PubMed  Google Scholar 

  40. Wilson PW, Kannel WB, Silbershatz H, D'Agostino RB. Clustering of metabolic factors and coronary heart disease. Arch Intern Med. 1999;159(10):1104–9.

    Article  CAS  PubMed  Google Scholar 

  41. Korner J, Inabnet W, Conwell IM, et al. Differential effects of gastric bypass and banding on circulating gut hormone and leptin levels. Obesity (Silver Spring). 2006;14:1553–61.

    Article  CAS  Google Scholar 

  42. Cummings DE, Overduin J, Foster-Schubert KE. Gastric bypass for obesity: mechanisms of weight loss and diabetes resolution. J Clin Endocrinol Metab. 2004;89(6):2608–15.

    Article  CAS  PubMed  Google Scholar 

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Acknowledgments

We would like to thank Stephanie Amlung, PhD, RN, USGI Medical, San Clemente, CA, USA for database integration and management and T. W. McGlennon, M3 LLC, Maiden Rock, Wisconsin, USA, for statistical analysis. We also thank Marcus Radauer, MSc and Jonas Philipp, MD (Austria) and Rochelle Nelissen (the Netherlands) for their assistance in this study.

Author information

Authors and Affiliations

  1. Bariatric Medical Unit, Wehrle Diakonissen Private Clinic, Salzburg, Austria

    Karl Miller

  2. Unidad de Endoscopia, Centro Médico Teknon, Barcelona, Catalonia, Spain

    R. Turró & J. C. Espinós

  3. Department of General Surgery, Bariatric and Gastrointestinal Surgery, Zuyderland Medical Center, Heerlen, The Netherlands

    J. W. Greve & C. M. Bakker

  4. Division of Scientific Research Writing, Medwrite Medical Communications, Maiden Rock, WI, USA

    J. N. Buchwald

Authors
  1. Karl Miller
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  2. R. Turró
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  3. J. W. Greve
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Corresponding author

Correspondence to Karl Miller.

Ethics declarations

Ethical Approval

As stated in the Methods, all procedures involving human participants were performed in this study in accordance with the ethical standards of the institutional and national research committees and with the 1964 Helsinki declaration and its later amendments.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

Disclosures

Manuscript development was financially supported by USGI Medical, Inc., San Clemente, CA, USA. Dr. Miller (Salzburg, Austria), Dr. Espinós (Barcelona, Spain), Dr. Turró (Barcelona, Spain), and Dr. Greve (Heerlen, the Netherlands) received investigator consulting fees from USGI Medical. J. N. Buchwald, Chief Scientific Research Writer and Director, Medwrite LLC, WI, USA received fees from USGI Medical for statistical analysis and manuscript development.

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Miller, K., Turró, R., Greve, J.W. et al. MILEPOST Multicenter Randomized Controlled Trial: 12-Month Weight Loss and Satiety Outcomes After pose SM vs. Medical Therapy. OBES SURG 27, 310–322 (2017). https://doi.org/10.1007/s11695-016-2295-9

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  • DOI: https://doi.org/10.1007/s11695-016-2295-9

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