Evidence map›Paper›PMID 23984050›Full record

Trial reportJournal of obesity2013

Vagal blocking improves glycemic control and elevated blood pressure in obese subjects with type 2 diabetes mellitus.

S Shikora, J Toouli, M F Herrera, B Kulseng, H Zulewski, R Brancatisano, L Kow, J P Pantoja, G Johnsen, A Brancatisano and 3 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Journal of obesity, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00555958 (VBLOC™ Clinical Trial), which is not on this map. Cited by 52 papers.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed
–field-weighted citation impact
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.

NCT00555958 naunknown statusnot on this map

VBLOC™ Clinical Trial: Vagal Block for Obesity Control

TypeinterventionalSponsorReShape LifesciencesRan2005 to 2014Enrolled120ConditionsObesityArmsActive, implantable, intra-abdominal vagal blocking medical device
3 · Its place in the literature

Who cites it

52 citing papers in PubMed.

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  12. Vagus nerve stimulation (VNS): recent advances and future directions.Clinical autonomic research : official journal of the Clinical Autonomic Research Society · 2024
    Review
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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

13 authors.

S ShikoraBrigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.
J Toouli
M F Herrera
B Kulseng
H Zulewski
R Brancatisano
L Kow
J P Pantoja
G Johnsen
A Brancatisano
K S Tweden
M B Knudson
C J Billington

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAn active device that downregulates abdominal vagal signalling has resulted in significant weight loss in feasibility studies.

objectiveTo prospectively evaluate the effect of intermittent vagal blocking (VBLOC) on weight loss, glycemic control, and blood pressure (BP) in obese subjects with DM2.

methodsTwenty-eight subjects were implanted with a VBLOC device (Maestro Rechargeable System) at 5 centers in an open-label study. Effects on weight loss, HbA1c, fasting blood glucose, and BP were evaluated at 1 week to 12 months.

results26 subjects (17 females/9 males, 51 ± 2 years, BMI 37 ± 1 kg/m(2), mean ± SEM) completed 12 months followup. One serious adverse event (pain at implant site) was easily resolved. At 1 week and 12 months, mean excess weight loss percentages (% EWL) were 9 ± 1% and 25 ± 4% (P < 0.0001), and HbA1c declined by 0.3 ± 0.1% and 1.0 ± 0.2% (P = 0.02, baseline 7.8 ± 0.2%). In DM2 subjects with elevated BP (n = 15), mean arterial pressure reduced by 7 ± 3 mmHg and 8 ± 3 mmHg (P = 0.04, baseline 100 ± 2 mmHg) at 1 week and 12 months. All subjects MAP decreased by 3 ± 2 mmHg (baseline 95 ± 2 mmHg) at 12 months.

conclusionsVBLOC was safe in obese DM2 subjects and associated with meaningful weight loss, early and sustained improvements in HbA1c, and reductions in BP in hypertensive DM2 subjects. This trial is registered with ClinicalTrials.gov NCT00555958.

Indexed as

Blood PressureVagotomyAustraliaBiomarkersBlood GlucoseDiabetes Mellitus, Type 2FemaleGlycated HemoglobinHumansHypertensionMaleMexicoMiddle AgedNorwayObesityProspective StudiesBiomarkersBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, human

Identifiers

PMID23984050
PMCPMC3745954

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Registered trials

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.