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

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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.

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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

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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.

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Authors and Affiliations

  1. Department of Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria

    Arthur Bohdjalian & Gerhard Prager

  2. Department of Medicine III, Division of Endocrinology and Metabolism, Medical University of Vienna, Waehringer Guertel 18–20, 1090, Vienna, Austria

    Karin Schindler & Bernhard Ludvik

  3. Sachsenhausen Hospital, Frankfurt, Germany

    Christoph Rosak, Rudolf Weiner, Ralf Jung & Markus Schramm

  4. MetaCure™ LIMITED, Tirat Carmel, Israel

    Ricardo Aviv, Walid Haddad & Norbert Rosenthal

Authors
  1. Arthur Bohdjalian
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  2. Gerhard Prager
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  3. Christoph Rosak
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  4. Rudolf Weiner
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  5. Ralf Jung
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  6. Markus Schramm
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  7. Ricardo Aviv
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  8. Karin Schindler
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  9. Walid Haddad
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  10. Norbert Rosenthal
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  11. Bernhard Ludvik
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Corresponding author

Correspondence to Bernhard Ludvik.

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Bohdjalian, A., Prager, G., Rosak, C. et al. Improvement in Glycemic Control in Morbidly Obese Type 2 Diabetic Subjects by Gastric Stimulation. OBES SURG 19, 1221–1227 (2009). https://doi.org/10.1007/s11695-009-9901-z

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  • DOI: https://doi.org/10.1007/s11695-009-9901-z

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