Sanmiguel Claudia P, Conklin Jeffrey L, Cunneen Scott A, Barnett Philip, Phillips Edward H, Kipnes Mark, Pilcher John, Soffer Edy E
Cedars Sinai Medical Center, Los Angeles, California, USA.
J Diabetes Sci Technol. 2009 Jul 1;3(4):964-70. doi: 10.1177/193229680900300445.
The TANTALUS System is an investigational device that consists of an implantable pulse generator connected to gastric electrodes. The system is designed to automatically detect when eating starts and only then deliver sessions of gastric electrical stimulation (GES) with electrical pulses that are synchronized to the intrinsic antral slow waves. We report the effect of this type of GES on weight loss and glucose control in overweight/obese subjects with type 2 diabetes mellitus (T2DM). This study was conducted under a Food and Drug Administration/Institutional Review Board-approved investigational device exemption.
Fourteen obese T2DM subjects on oral antidiabetes medication were enrolled and implanted laparoscopically with the TANTALUS System (body mass index 39 +/- 1 kg/m(2), hemoglobin A1c [HbA1c] 8.5 +/- 0.2%).Gastric electrical stimulation was initiated four weeks after implantation. Weight, HbA1c, fasting blood glucose, blood pressure, and lipid levels were assessed during the study period.
Eleven subjects reached the 6-month treatment period endpoint. Gastric electrical stimulation was well tolerated by all subjects. In those patients completing 6 months of therapy, HbA1c was reduced significantly from 8.5 +/- 0.7% to 7.6 +/- 1%, p < .01. Weight was also significantly reduced from 107.7 +/- 21.1 to 102.4 +/- 20.5 kg, p < .01. The improvement in glucose control did not correlate with weight loss (R(2) = 0.05, p = .44). A significant improvement was noted in blood pressure, triglycerides, and cholesterol (low-density lipoprotein only).
Short-term therapy with the TANTALUS System improves glucose control, induces weight loss, and improves blood pressure and lipids in obese T2DM subjects on oral antidiabetes therapy.
TANTALUS系统是一种研究性设备，由连接到胃电极的植入式脉冲发生器组成。该系统旨在自动检测进食开始的时间，然后仅在此时以与胃窦固有慢波同步的电脉冲进行胃电刺激（GES）治疗。我们报告了这种类型的GES对超重/肥胖的2型糖尿病（T2DM）患者体重减轻和血糖控制的影响。本研究是在食品药品监督管理局/机构审查委员会批准的研究性设备豁免下进行的。
招募了14名正在接受口服抗糖尿病药物治疗的肥胖T2DM患者，并通过腹腔镜植入TANTALUS系统（体重指数39±1kg/m²，糖化血红蛋白[HbA1c]8.5±0.2%）。植入后四周开始进行胃电刺激。在研究期间评估体重、HbA1c、空腹血糖、血压和血脂水平。
11名受试者达到了6个月治疗期终点。所有受试者对胃电刺激的耐受性良好。在完成6个月治疗的患者中，HbA1c从8.5±0.7%显著降低至7.6±1%，p<0.01。体重也从107.7±21.1kg显著降低至102.4±20.5kg，p<0.01。血糖控制的改善与体重减轻无关（R²=0.05，p=0.44）。血压、甘油三酯和胆固醇（仅低密度脂蛋白）有显著改善。
TANTALUS系统短期治疗可改善口服抗糖尿病治疗的肥胖T2DM患者的血糖控制，诱导体重减轻，并改善血压和血脂。
