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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

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An Erratum to this article was published on 02 November 2015

Abstract

Background

One-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.

Methods

VBLOC DM2 is a prospective, observational study of 28 subjects with T2DM and body mass index (BMI) between 30 and 40 kg/m2 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.

Results

At 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.

Conclusions

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

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Acknowledgments

We acknowledge Drs. Daniel Bessessen, James Freston, Miguel Herrera, Melissa Martinson, and Frank Moody for participation as members of the Data and Safety Monitoring Board and Clinical Events Committee. We also acknowledge Jody Dew for safety data reporting, Lisa Thackeray and Teresa Yurik for statistical analysis, and Brenda Bachmann, Jane Collins, Ruth Hutchinson, and Magnus Strommen for study coordination.

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Authors and Affiliations

  1. Brigham and Women’s Hospital, 75 Francis Street, Boston, MA, 02115, USA

    Scott A. Shikora

  2. EnteroMedics Inc, 2800 Patton Road, St. Paul, MN, 55113, USA

    Scott A. Shikora, Katherine S. Tweden & Mark B. Knudson

  3. Adelaide Bariatric Center, Flinders Private Hospital, Suite 502/Level 5, Bedford Park, SA, 5041, Australia

    James Toouli & Lilian Kow

  4. Instituto Nacional de al Nutricion, Salvador Zubrian (INNSZ), Vasco de Quiroga 15, Tlalpan, 1400, Mexico City, DF, Mexico

    Miguel F Herrera & Juan P. Pantoja

  5. Center for Obesity, St. Olavs Hospital, Olav Kyrres Gate 6, 7006, Trondheim, Norway

    Bård Kulseng & Gjermund Johnsen

  6. Institute of Weight Control, 495 Windsor Road, Baulkham Hills, NSW, 2153, Australia

    Roy Brancatisano & Anthony Brancatisano

  7. University of Minnesota, Minneapolis, Minnesota Veterans’ Administration Medical Center, One Veterans’ Drive, Minneapolis, MN, 55417, USA

    Charles J. Billingto

Authors
  1. Scott A. Shikora
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  2. James Toouli
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Corresponding author

Correspondence to Scott A. Shikora.

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Funding

EnteroMedics Inc. fully sponsored the VBLOC DM2 study. The study design, data collection, and data integrity are ensured by the sponsor, though data analysis was conducted by an independent contractor.

Conflict of Interest

Drs. Shikora, R. Brancatisano, and Billington have received support as consultants from EnteroMedics Inc. Drs. Tweden and Knudson are employees of EnteroMedics Inc. Drs. Herrera and Pantoja received support for proctoring from EnteroMedics Inc. Drs. Toouli, Kow, and A. Brancatisano have received support for traveling in the past from EnteroMedics Inc. Dr. Billington reports that he is a consultant for EnteroMedics and NovoNordisk and has received grant support from Covidien. Drs. Kulseng, Zulewski, and Johnsen report no conflicts of interest.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Shikora, S.A., Toouli, J., Herrera, M.F. et al. 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. OBES SURG 26, 1021–1028 (2016). https://doi.org/10.1007/s11695-015-1914-1

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