Evidence map›Paper›PMID 19067068›Full record

Trial reportSurgical endoscopy2009

Improvement in glycemic control by gastric electrical stimulation (TANTALUS) in overweight subjects with type 2 diabetes.

A Bohdjalian, B Ludvik, B Guerci, L Bresler, E Renard, D Nocca, E Karnieli, A Assalia, R Prager, G Prager

Abstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Surgical endoscopy, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Use of Bioelectronics in the Gastrointestinal Tract.Cold Spring Harbor perspectives in medicine · 2019
    Review
  6. Review
  7. Article
  8. Neurostimulation of the gastrointestinal tract: review of recent developments.Neuromodulation : journal of the International Neuromodulation Society · 2015
    Review
  9. The DIAMOND system in the treatment of type 2 diabetes mellitus in an obese patient.Wideochirurgia i inne techniki maloinwazyjne = Videosurgery and other miniinvasive techniques · 2014
    Article
  10. Article
  11. Article
  12. Article
  13. Gastric stimulation for weight loss.World journal of gastroenterology · 2012
    Review
  14. Review
  15. Article
  16. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 3 countries.

A BohdjalianMedical University of Vienna, Waehringer Guertel, 18-20, 1090, Vienna, Austria.
B Ludvik
B Guerci
L Bresler
E Renard
D Nocca
E Karnieli
A Assalia
R Prager
G Prager
Medical University of Vienna · ATHaifa Medical Center · ILHôpital Jeanne d'Arc · FRHôpital Lapeyronie · FRKlinik Hietzing · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

aimTo prospectively investigate the potential effect of the TANTALUS system on glycemic control and weight in overweight subjects with T2DM.

methodsIn 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.

resultsThirteen 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.

conclusionsInterim 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.

Indexed as

Electric Stimulation TherapyAfferent PathwaysBlood PressureCombined Modality TherapyDiabetes Mellitus, Type 2Electrodes, ImplantedFeasibility StudiesFemaleGastrointestinal MotilityGlycated HemoglobinHumansHypoglycemic AgentsLaparoscopyMaleObesityProspective StudiesGlycated HemoglobinHypoglycemic Agents

Identifiers

PMID19067068
OpenAlexW2025808036

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.