Vagal Blocking Improves Glycemic Control and Elevated Blood Pressure in Obese Subjects with Type 2 Diabetes Mellitus
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Shikora, S.
Brigham and Women’s Hospital, 75 Francis Street, Boston, MA 02115, USA
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Toouli, J.
Adelaide Bariatric Center, Flinders Private Hospital, Suite 502/Level 5, Bedford Park, SA, 5041, Australia
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Herrera, M. F.
Instituto Nacional de la Nutricion, Salvador Zubiran (INNSZ), Vasco de Quiroga 15, Tlalpan, 1400 Mexico City, DF, Mexico
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Kulseng, B.
Center for Obesity, St. Olavs Hospital, Olav Kyrres Gate 6, 7006 Trondheim, Norway
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Zulewski, H.
Division of Gastroenterology, University Hospital Basel, 4031 Basel, Switzerland
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Brancatisano, R.
Institute of Weight Control, 495 Windsor Road, Baulkham Hills, NSW 2153, Australia
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Kow, L.
Adelaide Bariatric Center, Flinders Private Hospital, Suite 502/Level 5, Bedford Park, SA, 5041, Australia
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Pantoja, J. P.
Instituto Nacional de la Nutricion, Salvador Zubiran (INNSZ), Vasco de Quiroga 15, Tlalpan, 1400 Mexico City, DF, Mexico
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Johnsen, G.
Center for Obesity, St. Olavs Hospital, Olav Kyrres Gate 6, 7006 Trondheim, Norway
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Brancatisano, A.
Institute of Weight Control, 495 Windsor Road, Baulkham Hills, NSW 2153, Australia
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Tweden, K. S.
EnteroMedics Inc., 2800 Patton Road, St. Paul, MN 55113, USA
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Knudson, M. B.
EnteroMedics Inc., 2800 Patton Road, St. Paul, MN 55113, USA
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Billington, C. J.
University of Minnesota, Minneapolis, Minnesota Veterans’ Administration Medical Center, One Veterans’ Drive, Minneapolis, MN 55417, USA
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Published in:
- Journal of Obesity. - Hindawi Limited. - 2013, vol. 2013, p. 1-8
English
Background. An active device that downregulates abdominal vagal signalling has resulted in significant weight loss in feasibility studies.Objective. To prospectively evaluate the effect of intermittent vagal blocking (VBLOC) on weight loss, glycemic control, and blood pressure (BP) in obese subjects with DM2.Methods. Twenty-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.Results. 26 subjects (17 females/9 males,51±2years, BMI37±1 kg/m2, 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) were9±1% and25±4% (P<0.0001), and HbA1cdeclined by0.3±0.1% and1.0±0.2% (P=0.02, baseline7.8±0.2%). In DM2 subjects with elevated BP (n=15), mean arterial pressure reduced by7±3 mmHg and8±3 mmHg (P=0.04, baseline100 ± 2 mmHg) at 1 week and 12 months. All subjects MAP decreased by3 ± 2 mmHg (baseline95 ± 2 mmHg) at 12 months.Conclusions. VBLOC 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.govNCT00555958.
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Open access status
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gold
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https://sonar.ch/global/documents/232140
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