Advertisement

Obesity Surgery

, Volume 19, Issue 9, pp 1221–1227 | Cite as

Improvement in Glycemic Control in Morbidly Obese Type 2 Diabetic Subjects by Gastric Stimulation

  • Arthur Bohdjalian
  • Gerhard Prager
  • Christoph Rosak
  • Rudolf Weiner
  • Ralf Jung
  • Markus Schramm
  • Ricardo Aviv
  • Karin Schindler
  • Walid Haddad
  • Norbert Rosenthal
  • Bernhard LudvikEmail author
Research Clinical

Abstract

Background

Gastric electrical stimulation synchronized to the refractory period of gastric electrical activity and applied during meals was evaluated for safety and for improvement of body weight and glycemic control in obese type 2 diabetes.

Methods

The study involved obese diabetic type 2 (ODM) patients in a multicenter open-label European feasibility trial. A total of 24 ODM (nine males, 15 females) treated with insulin and/or oral hyperglycemic agents and body mass index between 33.3 to 49.7 kg/m2 were implanted laparoscopically with a TANTALUS system.

Results

There were 18 adverse events related to the implant procedure or the device reported in 12 subjects. All were short lived and resolved with no sequelae. In the 21 subjects that reached the 1-year visit weight was reduced by 4.5 ± 2.7 kg (p < 0.05) and HbA1c by 0.5 ± 0.3% (p < 0.05). In a subgroup (n = 11) on stable or reduced oral medication, weight was reduced by 6.3 ± 3.4 kg (p < 0.05) and HbA1c by 0.9 ± 0.4% (p < 0.05). The group on insulin (n = 6) had no significant changes in weight and HbA1c.

Conclusions

The TANTALUS system is well tolerated in obese type 2 diabetic subjects. Gastric electrical stimulation can potentially improve glucose metabolism and induce weight loss in obese diabetic patients, who are not well controlled on oral antidiabetic therapy. Further evaluation is required to determine whether this effect is due to induced weight loss and/or to direct signal dependent mechanisms.

Keywords

Gastric pacemaker Gastric stimulation Laparoscopy Weight loss Gastric contractility modulation Glycemic control 

Abbreviations

EWL

Excess weight loss

TFEQ

Three-Factor Eating Questionnaire

BMI

Body mass index

GCM

Gastric contractility modulation

PP

Postprandrial

BT

Bed time

GE

Gastric emptying

FBG

Fasting blood glucose

BL

Baseline

Notes

Acknowledgments

This work was supported by a research grant from MetaCure (USA) Inc, Orangeburg, NY. TANTALUS™ system is a registered trademark of MetaCure NV, Inc.

References

  1. 1.
    Engelgau MM, Geiss LS, Saaddine JB, et al. The evolving diabetes burden in the United States. Ann Intern Med. 2004;140:945–50.CrossRefGoogle Scholar
  2. 2.
    Kopelman PG, Hitman GA. Diabetes: exploding type II. Lancet. 1998;352(Suppl. 4):5.CrossRefGoogle Scholar
  3. 3.
    Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004;292:1724–37.CrossRefGoogle Scholar
  4. 4.
    Moo TA, Rubino F. Gastrointestinal surgery as treatment for type 2 diabetes. Curr Opin Endocrinol Diabetes Obes. 2008;2:153–8.CrossRefGoogle Scholar
  5. 5.
    Bohdjalian A, Prager G, Aviv R, et al. One-year experience with Tantalus: a new surgical approach to treat morbid obesity. Obes Surg. 2006;5:627–34.CrossRefGoogle Scholar
  6. 6.
    Peles S, Petersen J, Aviv R, et al. Enhancement of antral contractions and vagal afferent signaling with synchronized electrical stimulation. Am J Physiol Gastrointest Liver Physiol. 2003;285:G577–85.CrossRefGoogle Scholar
  7. 7.
    Sanmiguel CP, Aviv R, Policker S, et al. Association between gastric electromechanical activity and satiation in dogs. Obesity. 2007;15(12):2958–63.CrossRefGoogle Scholar
  8. 8.
    Pocai A, Lam TK, Gutierrez-Juarez R, et al. Hypothalamic K(ATP) channels control hepatic glucose production. Nature. 2005;434:1026–31.CrossRefGoogle Scholar
  9. 9.
    Libert C. Inflammation: a nervous connection. Nature. 2003;421:328–9.CrossRefGoogle Scholar
  10. 10.
    Sanmiguel CP, Haddad W, Aviv R, et al. The TANTALUS trade mark system for obesity: effect on gastric emptying of solids and ghrelin plasma levels. Obes Surg. 2007;17:1503–9.CrossRefGoogle Scholar
  11. 11.
    Neeley WE. Simply automated determination of serum or plasma glucose by a hexokinase/glucose-6-phosphate dehydrogenase method. Clin Chem. 1972;18:509–15.PubMedGoogle Scholar
  12. 12.
    Dunn PJ, Cole RA, Soeldner JS. Further development and automation of a high pressure liquid chromatography method for the determination of glycosylated hemoglobins. Metabolism. 1979;28:777–9.CrossRefGoogle Scholar
  13. 13.
    Albert J, Stunkard AJ, Samuel M. The three factors eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29:71–83.CrossRefGoogle Scholar
  14. 14.
    Lundberg GD. How to reduce laparoscopy-induced shoulder pain. Medscape J Med. 2008;10:173.PubMedPubMedCentralGoogle Scholar
  15. 15.
    De Vries J, De Jongste MJ, Spincemaille G, Staal MJ. Spinal cord stimulation for ischemic heart disease and peripheral vascular disease. Adv Tech Stand Neurosurg. 2007;32:63–89.CrossRefGoogle Scholar
  16. 16.
    Zhang J, Chen JD. Pacing the gut in motility disorders. Curr Treat Options Gastroenterol. 2006;9:351–60.CrossRefGoogle Scholar
  17. 17.
    Policker S, Lu H, Haddad W, et al. Electrical stimulation of the gut for the treatment of type 2 diabetes: effect of automatic eating detection. J Diabetes Sci Technol. 2008;2:904–12.CrossRefGoogle Scholar
  18. 18.
    Dockray GJ. The brain-gut axis. In: Yamada T, editor. Basic mechanisms of normal and abnormal gastrointestinal function. 4th ed. Philadelphia: Lippincott Williams & Wilkins; 2003. p. 77–91.Google Scholar
  19. 19.
    Sobocki J, Thor PJ, Uson J, et al. Microchip vagal pacing reduces food intake and body mass. Hepatogastroenterology. 2001;48:1783–7.PubMedGoogle Scholar
  20. 20.
    Rocca AS, Brubaker PL. Role of the vagus nerve in mediating proximal nutrient-induced glucagon-like peptide-1 secretion. Endocrinology. 1999;140:1687–94.CrossRefGoogle Scholar
  21. 21.
    Andrews PL, Sanger GJ. Abdominal vagal afferent neurones: an important target for the treatment of gastrointestinal dysfunction. Curr Opin Pharmacol. 2002;6:650–6.CrossRefGoogle Scholar
  22. 22.
    Strader AD, Woods SC. Gastrointestinal hormones and food intake. Gastroenterology. 2005;128:175–91.CrossRefGoogle Scholar
  23. 23.
    Liu S, Lei Y, Chen JD. Inhibitory effects and mechanisms of colonic electric stimulation on gastric and rectal tone in conscious dogs. Dis Colon Rectum. 2006;49:1749–54.CrossRefGoogle Scholar

Copyright information

© Springer Science + Business Media, LLC 2009

Authors and Affiliations

  • Arthur Bohdjalian
    • 1
  • Gerhard Prager
    • 1
  • Christoph Rosak
    • 3
  • Rudolf Weiner
    • 3
  • Ralf Jung
    • 3
  • Markus Schramm
    • 3
  • Ricardo Aviv
    • 4
  • Karin Schindler
    • 2
  • Walid Haddad
    • 4
  • Norbert Rosenthal
    • 4
  • Bernhard Ludvik
    • 2
    Email author
  1. 1.Department of SurgeryMedical University of ViennaViennaAustria
  2. 2.Department of Medicine III, Division of Endocrinology and MetabolismMedical University of ViennaViennaAustria
  3. 3.Sachsenhausen HospitalFrankfurtGermany
  4. 4.MetaCure™ LIMITEDTirat CarmelIsrael

Personalised recommendations