Centro de Cirugía de la Obesidad, Hospital Dipreca, Las Condes, Santiago de Chile, Chile.
Diabetes Technol Ther. 2009 Nov;11(11):725-32. doi: 10.1089/dia.2009.0063.
Bariatric surgery is associated with the rapid improvement of type 2 diabetes (T2DM). Here we report an exploratory trial of a completely endoscopic, removable, duodenal-jejunal bypass liner (DJBL) intended to treat T2DM.
Obese T2DM subjects were randomized to receive a DJBL (n = 12) or sham endoscopy (n = 6) in a 24-week study, extended up to 52 weeks. Measurements included weights, hemoglobin A1c (HbA(1c)), meal tolerance testing, fasting glucose, and seven-point glucose profiles. Subjects' diets were adjusted in the first 2 weeks to obtain similar weight loss during this period.
Subjects had baseline HbA(1c) of 9.1 +/- 1.7% and body mass index of 38.9 +/- 6.1 kg/m(2) (+/- SD). In the completer population by week 1, change in fasting glucose in the DJBL arm was -55 +/- 21 mg/dL versus +42 +/- 30 mg/dL in the sham arm (P < or = 0.05; +/- SE); the seven-point glucose profiles were reduced in the DJBL arm but not in the sham arm. Mean postprandial glucose area under the curve was reduced in the DJBL arm by 20% and increased 17% in the sham arm (P = 0.016). At week 12, HbA(1c) change was -1.3 +/- 0.9% in the DJBL arm and -0.7 +/- 0.4% in the sham arm (P > 0.05), and at 24 weeks, values were -2.4 +/- 0.7% in the DJBL arm and -0.8 +/- 0.4% in the sham arm (P > 0.05). Device migrations required endoscopic removal prior to reaching 52 weeks.
The DJBL rapidly normalized glycemic control in obese T2DM subjects, a promising development in the search for novel therapies less invasive than bariatric surgery.
减重手术与 2 型糖尿病（T2DM）的迅速改善有关。在这里，我们报告了一项完全内镜、可移除的十二指肠空肠旁路管（DJBL）的探索性试验，旨在治疗 T2DM。
肥胖的 T2DM 受试者被随机分配接受 DJBL（n = 12）或假内镜（n = 6）治疗，研究时间为 24 周，并延长至 52 周。测量包括体重、糖化血红蛋白（HbA（1c））、餐耐量试验、空腹血糖和七点血糖谱。在最初的 2 周内调整受试者的饮食，以使这期间的体重减轻相似。
受试者的基线 HbA（1c）为 9.1 +/- 1.7%，体重指数为 38.9 +/- 6.1 kg/m（2）（+/- SD）。在第 1 周的完成人群中，DJBL 组空腹血糖的变化为-55 +/- 21 mg/dL，而假内镜组为+42 +/- 30 mg/dL（P < or = 0.05； +/- SE）；DJBL 组的七点血糖谱降低，但假内镜组没有。DJBL 组餐后血糖曲线下面积减少 20%，假内镜组增加 17%（P = 0.016）。第 12 周时，DJBL 组的 HbA（1c）变化为-1.3 +/- 0.9%，假内镜组为-0.7 +/- 0.4%（P > 0.05），第 24 周时，DJBL 组为-2.4 +/- 0.7%，假内镜组为-0.8 +/- 0.4%（P > 0.05）。在达到 52 周之前，由于器械迁移需要内镜取出。
DJBL 可迅速使肥胖的 T2DM 受试者的血糖控制正常化，这是寻找比减重手术侵入性更小的新型治疗方法的一个有希望的进展。
