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Obes Surg. 2016 May;26(5):1021-8. doi: 10.1007/s11695-015-1914-1.

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.

Author information

1
Brigham and Women's Hospital, 75 Francis Street, Boston, MA, 02115, USA. sshikora@partners.org.
2
EnteroMedics Inc, 2800 Patton Road, St. Paul, MN, 55113, USA. sshikora@partners.org.
3
Adelaide Bariatric Center, Flinders Private Hospital, Suite 502/Level 5, Bedford Park, SA, 5041, Australia.
4
Instituto Nacional de al Nutricion, Salvador Zubrian (INNSZ), Vasco de Quiroga 15, Tlalpan, 1400, Mexico City, DF, Mexico.
5
Center for Obesity, St. Olavs Hospital, Olav Kyrres Gate 6, 7006, Trondheim, Norway.
6
Institute of Weight Control, 495 Windsor Road, Baulkham Hills, NSW, 2153, Australia.
7
EnteroMedics Inc, 2800 Patton Road, St. Paul, MN, 55113, USA.
8
University of Minnesota, Minneapolis, Minnesota Veterans' Administration Medical Center, One Veterans' Drive, Minneapolis, MN, 55417, USA.

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/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.

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.

KEYWORDS:

Obesity; Type 2 diabetes mellitus; VBLOC

PMID:
26471783
DOI:
10.1007/s11695-015-1914-1
[Indexed for MEDLINE]

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