title: Vagal blocking improves glycemic control and elevated blood pressure in obese subjects with type 2 diabetes mellitus.
abstract: 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 ± 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.
  
  
  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.gov NCT00555958.
authors: Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.
authors: S
authors: S
authors: Shikora
authors: J
authors: J
authors: Toouli
authors: M F
authors: MF
authors: Herrera
authors: B
authors: B
authors: Kulseng
authors: H
authors: H
authors: Zulewski
authors: R
authors: R
authors: Brancatisano
authors: L
authors: L
authors: Kow
authors: J P
authors: JP
authors: Pantoja
authors: G
authors: G
authors: Johnsen
authors: A
authors: A
authors: Brancatisano
authors: K S
authors: KS
authors: Tweden
authors: M B
authors: MB
authors: Knudson
authors: C J
authors: CJ
authors: Billington
mesh_terms: D001315:Australia; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism*; D001794:Blood Pressure; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D006973:Hypertension / Q000097:blood / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008800:Mexico; D008875:Middle Aged; D009664:Norway; D009765:Obesity / Q000097:blood / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D011446:Prospective Studies; D016896:Treatment Outcome; D014628:Vagotomy / Q000295:instrumentation; D014630:Vagus Nerve / Q000503:physiopathology*; D015431:Weight Loss
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human
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