PMID- 19067068
OWN - NLM
STAT- MEDLINE
DCOM- 20091216
LR  - 20221207
IS  - 1432-2218 (Electronic)
IS  - 0930-2794 (Linking)
VI  - 23
IP  - 9
DP  - 2009 Sep
TI  - Improvement in glycemic control by gastric electrical stimulation (TANTALUS) in 
      overweight subjects with type 2 diabetes.
PG  - 1955-60
LID - 10.1007/s00464-008-0222-4 [doi]
AB  - BACKGROUND: The TANTALUS system (MetaCure Ltd.) is a minimally invasive 
      implantable gastric stimulation modality that does not exhibit malabsorptive or 
      restrictive characteristics. The device applies gastric contractility modulation 
      (GCM) signals to the stomach antrum. The signals are delivered in synchronization 
      to the native electrical activity of the stomach during meals. Retrospective 
      analysis of previous studies indicated that type 2 diabetes mellitus (T2DM) 
      subjects on oral medication with hemoglobin A1c (HbA1c) between 7.5% and 9.5% are 
      the population with most potential benefit from the treatment. The current study 
      includes subjects enrolled prospectively within that range of HbA1c. AIM: To 
      prospectively investigate the potential effect of the TANTALUS system on glycemic 
      control and weight in overweight subjects with T2DM. METHODS: In this European 
      multicenter, open-label study, 13 T2DM obese (6 male, 7 female, BMI 37.2 +/- 1.0 
      kg/m(2), range 30.4-44.0 kg/m(2)) subjects treated with oral antidiabetic 
      medications but with poor glycemic control (HbA1c > or = 7%, range 7.3-9.5%) were 
      implanted laparoscopically with the TANTALUS system. RESULTS: Thirteen subjects 
      that had completed 3 months of treatment showed a significant reduction in HbA1c 
      from 8.0 +/- 0.2% to 6.9 +/- 0.1% (p < 0.05), whereas fasting blood glucose 
      decreased from 175 +/- 6 mg/dL to 127 +/- 8 mg/dL (p < 0.05). The glycemic 
      improvement was accompanied by reduction in weight from 104.4 +/- 4.4 kg to 99.7 
      +/- 4.8 kg, and in waist circumference from 122.3 +/- 3.2 cm to 117.0 +/- 3.0 cm. 
      CONCLUSIONS: Interim results with the TANTALUS system suggest that this 
      stimulation regime can potentially improve glucose levels and induce moderate 
      weight loss in obese T2DM subjects on oral antidiabetic therapy with poor 
      glycemic control. Further evaluation is required to determine whether this effect 
      is due to induced weight loss and/or due to direct signal-dependent mechanisms.
FAU - Bohdjalian, A
AU  - Bohdjalian A
AD  - Medical University of Vienna, Waehringer Guertel, 18-20, 1090, Vienna, Austria.
FAU - Ludvik, B
AU  - Ludvik B
FAU - Guerci, B
AU  - Guerci B
FAU - Bresler, L
AU  - Bresler L
FAU - Renard, E
AU  - Renard E
FAU - Nocca, D
AU  - Nocca D
FAU - Karnieli, E
AU  - Karnieli E
FAU - Assalia, A
AU  - Assalia A
FAU - Prager, R
AU  - Prager R
FAU - Prager, G
AU  - Prager G
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20081206
PL  - Germany
TA  - Surg Endosc
JT  - Surgical endoscopy
JID - 8806653
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
SB  - IM
MH  - Afferent Pathways/physiology
MH  - Blood Pressure
MH  - Combined Modality Therapy
MH  - Diabetes Mellitus, Type 2/blood/complications/drug therapy/*therapy
MH  - *Electric Stimulation Therapy
MH  - Electrodes, Implanted
MH  - Feasibility Studies
MH  - Female
MH  - Gastrointestinal Motility
MH  - Glycated Hemoglobin/*analysis
MH  - Humans
MH  - Hypoglycemic Agents/therapeutic use
MH  - Laparoscopy
MH  - Male
MH  - Obesity/complications/*therapy
MH  - Prospective Studies
MH  - Pyloric Antrum
MH  - Waist Circumference
EDAT- 2008/12/11 09:00
MHDA- 2009/12/17 06:00
CRDT- 2008/12/11 09:00
PHST- 2008/06/11 00:00 [received]
PHST- 2008/10/13 00:00 [accepted]
PHST- 2008/12/11 09:00 [pubmed]
PHST- 2009/12/17 06:00 [medline]
PHST- 2008/12/11 09:00 [entrez]
AID - 10.1007/s00464-008-0222-4 [doi]
PST - ppublish
SO  - Surg Endosc. 2009 Sep;23(9):1955-60. doi: 10.1007/s00464-008-0222-4. Epub 2008 
      Dec 6.