Shikora S, Toouli J, Herrera M F, Kulseng B, Zulewski H, Brancatisano R, Kow L, Pantoja J P, Johnsen G, Brancatisano A, Tweden K S, Knudson M B, Billington C J
Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.
J Obes. 2013;2013:245683. doi: 10.1155/2013/245683. Epub 2013 Jul 30.
An active device that downregulates abdominal vagal signalling has resulted in significant weight loss in feasibility studies.
To prospectively evaluate the effect of intermittent vagal blocking (VBLOC) on weight loss, glycemic control, and blood pressure (BP) in obese subjects with DM2.
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.
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.
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.
一种可下调腹部迷走神经信号的有源装置在可行性研究中已导致显著体重减轻。
前瞻性评估间歇性迷走神经阻断（VBLOC）对2型糖尿病（DM2）肥胖受试者体重减轻、血糖控制和血压（BP）的影响。
在一项开放标签研究中，28名受试者在5个中心植入了VBLOC装置（Maestro可充电系统）。在1周、3个月、6个月、9个月和12个月时评估对体重减轻、糖化血红蛋白（HbA1c）、空腹血糖和血压的影响。
26名受试者（17名女性/9名男性，51±2岁，体重指数[BMI]37±1kg/m²，均值±标准误）完成了12个月的随访。1例严重不良事件（植入部位疼痛）很容易得到解决。在1周和12个月时，平均超重减轻百分比（%EWL）分别为9±1%和25±4%（P<0.0001），HbA1c分别下降了0.3±0.1%和1.0±0.2%（P=0.02，基线值7.8±0.2%）。在血压升高的DM2受试者（n=15）中，平均动脉压在1周和12个月时分别降低了7±3mmHg和8±3mmHg（P=0.04，基线值100±2mmHg）。所有受试者的平均动脉压在12个月时下降了3±2mmHg（基线值95±2mmHg）。
VBLOC在肥胖的DM2受试者中是安全的，并且与有意义的体重减轻、HbA1c的早期和持续改善以及高血压DM2受试者的血压降低相关。本试验已在ClinicalTrials.gov注册，注册号为NCT00555958。
