Vagal Blocking Improves Glycemic Control and Elevated Blood Pressure in Obese Subjects with Type 2 Diabetes Mellitus
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 subject...
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| Format: | Article |
| Language: | English |
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Wiley
2013-01-01
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| Series: | Journal of Obesity |
| Online Access: | http://dx.doi.org/10.1155/2013/245683 |
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| author | S. Shikora J. Toouli M. F. Herrera B. Kulseng H. Zulewski R. Brancatisano L. Kow J. P. Pantoja G. Johnsen A. Brancatisano K. S. Tweden M. B. Knudson C. J. Billington |
| author_facet | S. Shikora J. Toouli M. F. Herrera B. Kulseng H. Zulewski R. Brancatisano L. Kow J. P. Pantoja G. Johnsen A. Brancatisano K. S. Tweden M. B. Knudson C. J. Billington |
| author_sort | S. Shikora |
| collection | DOAJ |
| description | 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/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) 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. |
| format | Article |
| id | doaj-art-d5b5b5b735c84590a0559d3756444585 |
| institution | Kabale University |
| issn | 2090-0708 2090-0716 |
| language | English |
| publishDate | 2013-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Obesity |
| spelling | doaj-art-d5b5b5b735c84590a0559d37564445852025-02-03T05:43:42ZengWileyJournal of Obesity2090-07082090-07162013-01-01201310.1155/2013/245683245683Vagal Blocking Improves Glycemic Control and Elevated Blood Pressure in Obese Subjects with Type 2 Diabetes MellitusS. Shikora0J. Toouli1M. F. Herrera2B. Kulseng3H. Zulewski4R. Brancatisano5L. Kow6J. P. Pantoja7G. Johnsen8A. Brancatisano9K. S. Tweden10M. B. Knudson11C. J. Billington12Brigham and Women’s Hospital, 75 Francis Street, Boston, MA 02115, USAAdelaide Bariatric Center, Flinders Private Hospital, Suite 502/Level 5, Bedford Park, SA, 5041, AustraliaInstituto Nacional de la Nutricion, Salvador Zubiran (INNSZ), Vasco de Quiroga 15, Tlalpan, 1400 Mexico City, DF, MexicoCenter for Obesity, St. Olavs Hospital, Olav Kyrres Gate 6, 7006 Trondheim, NorwayDivision of Gastroenterology, University Hospital Basel, 4031 Basel, SwitzerlandInstitute of Weight Control, 495 Windsor Road, Baulkham Hills, NSW 2153, AustraliaAdelaide Bariatric Center, Flinders Private Hospital, Suite 502/Level 5, Bedford Park, SA, 5041, AustraliaInstituto Nacional de la Nutricion, Salvador Zubiran (INNSZ), Vasco de Quiroga 15, Tlalpan, 1400 Mexico City, DF, MexicoCenter for Obesity, St. Olavs Hospital, Olav Kyrres Gate 6, 7006 Trondheim, NorwayInstitute of Weight Control, 495 Windsor Road, Baulkham Hills, NSW 2153, AustraliaEnteroMedics Inc., 2800 Patton Road, St. Paul, MN 55113, USAEnteroMedics Inc., 2800 Patton Road, St. Paul, MN 55113, USAUniversity of Minnesota, Minneapolis, Minnesota Veterans’ Administration Medical Center, One Veterans’ Drive, Minneapolis, MN 55417, USABackground. 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/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) 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.http://dx.doi.org/10.1155/2013/245683 |
| spellingShingle | S. Shikora J. Toouli M. F. Herrera B. Kulseng H. Zulewski R. Brancatisano L. Kow J. P. Pantoja G. Johnsen A. Brancatisano K. S. Tweden M. B. Knudson C. J. Billington Vagal Blocking Improves Glycemic Control and Elevated Blood Pressure in Obese Subjects with Type 2 Diabetes Mellitus Journal of Obesity |
| title | Vagal Blocking Improves Glycemic Control and Elevated Blood Pressure in Obese Subjects with Type 2 Diabetes Mellitus |
| title_full | Vagal Blocking Improves Glycemic Control and Elevated Blood Pressure in Obese Subjects with Type 2 Diabetes Mellitus |
| title_fullStr | Vagal Blocking Improves Glycemic Control and Elevated Blood Pressure in Obese Subjects with Type 2 Diabetes Mellitus |
| title_full_unstemmed | Vagal Blocking Improves Glycemic Control and Elevated Blood Pressure in Obese Subjects with Type 2 Diabetes Mellitus |
| title_short | Vagal Blocking Improves Glycemic Control and Elevated Blood Pressure in Obese Subjects with Type 2 Diabetes Mellitus |
| title_sort | vagal blocking improves glycemic control and elevated blood pressure in obese subjects with type 2 diabetes mellitus |
| url | http://dx.doi.org/10.1155/2013/245683 |
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