title: 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.
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.
authors.affiliation: Brigham and Women's Hospital, 75 Francis Street, Boston, MA, 02115, USA. sshikora@partners.org.|EnteroMedics Inc, 2800 Patton Road, St. Paul, MN, 55113, USA. sshikora@partners.org.
authors.forename: Scott A
authors.initials: SA
authors.lastname: Shikora
authors.affiliation: Adelaide Bariatric Center, Flinders Private Hospital, Suite 502/Level 5, Bedford Park, SA, 5041, Australia.
authors.forename: James
authors.initials: J
authors.lastname: Toouli
authors.affiliation: Instituto Nacional de al Nutricion, Salvador Zubrian (INNSZ), Vasco de Quiroga 15, Tlalpan, 1400, Mexico City, DF, Mexico.
authors.forename: Miguel F
authors.initials: MF
authors.lastname: Herrera
authors.affiliation: Center for Obesity, St. Olavs Hospital, Olav Kyrres Gate 6, 7006, Trondheim, Norway.
authors.forename: Bård
authors.initials: B
authors.lastname: Kulseng
authors.affiliation: Institute of Weight Control, 495 Windsor Road, Baulkham Hills, NSW, 2153, Australia.
authors.forename: Roy
authors.initials: R
authors.lastname: Brancatisano
authors.affiliation: Adelaide Bariatric Center, Flinders Private Hospital, Suite 502/Level 5, Bedford Park, SA, 5041, Australia.
authors.forename: Lilian
authors.initials: L
authors.lastname: Kow
authors.affiliation: Instituto Nacional de al Nutricion, Salvador Zubrian (INNSZ), Vasco de Quiroga 15, Tlalpan, 1400, Mexico City, DF, Mexico.
authors.forename: Juan P
authors.initials: JP
authors.lastname: Pantoja
authors.affiliation: Center for Obesity, St. Olavs Hospital, Olav Kyrres Gate 6, 7006, Trondheim, Norway.
authors.forename: Gjermund
authors.initials: G
authors.lastname: Johnsen
authors.affiliation: Institute of Weight Control, 495 Windsor Road, Baulkham Hills, NSW, 2153, Australia.
authors.forename: Anthony
authors.initials: A
authors.lastname: Brancatisano
authors.affiliation: EnteroMedics Inc, 2800 Patton Road, St. Paul, MN, 55113, USA.
authors.forename: Katherine S
authors.initials: KS
authors.lastname: Tweden
authors.affiliation: EnteroMedics Inc, 2800 Patton Road, St. Paul, MN, 55113, USA.
authors.forename: Mark B
authors.initials: MB
authors.lastname: Knudson
authors.affiliation: University of Minnesota, Minneapolis, Minnesota Veterans' Administration Medical Center, One Veterans' Drive, Minneapolis, MN, 55417, USA.
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Billington
authors.affiliation: University of Minnesota, Minneapolis, Minnesota Veterans' Administration Medical Center, One Veterans' Drive, Minneapolis, MN, 55417, USA.
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Billingto
mesh_terms: D000328:Adult; D001340:Autonomic Nerve Block / Q000379:methods*; D001786:Blood Glucose / Q000378:metabolism*; D002318:Cardiovascular Diseases / Q000097:blood / Q000209:etiology*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000097:blood / Q000150:complications* / Q000601:surgery*; D012307:Risk Factors; D014630:Vagus Nerve / Q000601:surgery*; D015431:Weight Loss / Q000502:physiology
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin
keywords: Obesity; Type 2 diabetes mellitus; VBLOC