Evidence map›Paper›PMID 26471783›Full record

Observational studyObesity surgery2016

Intermittent Vagal Nerve Block for Improvements in Obesity, Cardiovascular Risk Factors, and Glycemic Control in Patients with Type 2 Diabetes Mellitus: 2-Year Results of the VBLOC DM2 Study.

Scott A Shikora, James Toouli, Miguel F Herrera, Bård Kulseng, Roy Brancatisano, Lilian Kow, Juan P Pantoja, Gjermund Johnsen, Anthony Brancatisano, Katherine S Tweden and 3 more

Erratum issuedAbstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Obesity surgery, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
4.5field-weighted citation impact, top 6% 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

20 citing papers in PubMed, 43 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
  7. Electroceuticals in the Gastrointestinal Tract.Trends in pharmacological sciences · 2020
    Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. The vagus neurometabolic interface and clinical disease.International journal of obesity (2005) · 2018
    Review
  13. Review
  14. Brain stimulation in obesity.International journal of obesity (2005) · 2017
    Review
  15. Article
  16. Article
  17. Review
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 4 countries.

Scott A ShikoraBrigham and Women's Hospital, 75 Francis Street, Boston, MA, 02115, USA. sshikora@partners.org.
James ToouliAdelaide Bariatric Center, Flinders Private Hospital, Suite 502/Level 5, Bedford Park, SA, 5041, Australia.
Miguel F HerreraInstituto Nacional de al Nutricion, Salvador Zubrian (INNSZ), Vasco de Quiroga 15, Tlalpan, 1400, Mexico City, DF, Mexico.
Bård KulsengCenter for Obesity, St. Olavs Hospital, Olav Kyrres Gate 6, 7006, Trondheim, Norway.
Roy BrancatisanoInstitute of Weight Control, 495 Windsor Road, Baulkham Hills, NSW, 2153, Australia.
Lilian KowAdelaide Bariatric Center, Flinders Private Hospital, Suite 502/Level 5, Bedford Park, SA, 5041, Australia.
Juan P PantojaInstituto Nacional de al Nutricion, Salvador Zubrian (INNSZ), Vasco de Quiroga 15, Tlalpan, 1400, Mexico City, DF, Mexico.
Gjermund JohnsenCenter for Obesity, St. Olavs Hospital, Olav Kyrres Gate 6, 7006, Trondheim, Norway.
Anthony BrancatisanoInstitute of Weight Control, 495 Windsor Road, Baulkham Hills, NSW, 2153, Australia.
Katherine S TwedenEnteroMedics Inc, 2800 Patton Road, St. Paul, MN, 55113, USA.
Mark B KnudsonEnteroMedics Inc, 2800 Patton Road, St. Paul, MN, 55113, USA.
Charles J BillingtonUniversity of Minnesota, Minneapolis, Minnesota Veterans' Administration Medical Center, One Veterans' Drive, Minneapolis, MN, 55417, USA.
Charles J BillingtoUniversity of Minnesota, Minneapolis, Minnesota Veterans' Administration Medical Center, One Veterans' Drive, Minneapolis, MN, 55417, USA.
Circle of Care · AUFlinders Private Hospital · AUInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán · MXReShape Lifesciences (United States) · USSt Olav's University Hospital · NOBrigham and Women's Hospital · USUniversity of Minnesota · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOne-year results of the VBLOC DM2 study found that intermittent vagal blocking (VBLOC therapy) was safe among subjects with obesity and type 2 diabetes mellitus (T2DM) and led to significant weight loss and improvements in glycemic parameters and cardiovascular risk factors. Longer-term data are needed to determine whether the results are sustained.

methodsVBLOC DM2 is a prospective, observational study of 28 subjects with T2DM and body mass index (BMI) between 30 and 40 kg/m(2) to assess mid-term safety and weight loss and improvements in glycemic parameters, and other cardiovascular risk factors with VBLOC therapy. Continuous outcome variables are reported using mixed models.

resultsAt 24 months, the mean percentage of excess weight loss was 22% (95% CI, 15 to 28, p < 0.0001) or 7.0% total body weight loss (95% CI, 5.0 to 9.0, p < 0.0001). Hemoglobin A1c decreased by 0.6 percentage points (95% CI, 0.2 to 1.0, p = 0.0026) on average from 7.8% at baseline. Fasting plasma glucose declined by 15 mg/dL (95% CI, 0 to 29, p = 0.0564) on average from 151 mg/dL at baseline. Among subjects who were hypertensive at baseline, systolic blood pressure declined 10 mmHg (95% CI, 2 to 19, p = 0.02), diastolic blood pressure declined by 6 mmHg (95% CI, 0 to 12, p = 0.0423), and mean arterial pressure declined 7 mmHg (95% CI, 2 to 13, p = 0.014). Waist circumference was significantly reduced by 7 cm (95% CI, 4 to 10, p < 0.0001) from a baseline of 120 cm. The most common adverse events were mild or moderate heartburn, implant site pain, and constipation.

conclusionsImprovements in obesity and glycemic control were largely sustained after 2 years of treatment with VBLOC therapy with a well-tolerated risk profile.

Indexed as

AdultAutonomic Nerve BlockBlood GlucoseCardiovascular DiseasesDiabetes Mellitus, Type 2FemaleFollow-Up StudiesGlycated HemoglobinHumansMaleMiddle AgedObesityRisk FactorsVagus NerveWeight LossBlood GlucoseGlycated HemoglobinObesityType 2 diabetes mellitusVBLOC

Identifiers

PMID26471783
OpenAlexW4245675916

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.