Departments of Endocrinology and Diabetology, University Hospital Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.
Obes Surg. 2013 Nov;23(11):1727-33. doi: 10.1007/s11695-013-1005-0.
The endoluminal mechanical device SatiSphere is a new endoscopically implantable device designed to delay transit time of nutrients through the duodenum. It consists of a 1-mm nitinol wire with pigtail ends and several mesh spheres mounted along its course, released in the duodenum and gastric antrum to conform to the duodenal C loop configuration and thereby self-anchor.
The objective is to test the safety, efficacy, and effect on body weight in a 2:1 randomized study, as well as incretin secretion in a subgroup.
Of 31 included cases (11 men, mean age 42.9 years, mean BMI 41.3 kg/m2), 21 patients treated with endoscopic device insertion with scheduled device removal after 3 months were compared with 10 controls. In 10 of 21 patients, device migration occurred, in two cases necessitating emergency surgery, which led to termination of the trial. Weight loss after 3 months was 6.7, 4.6, and 2.2 kg in the groups completing therapy, all treatment cases using intention to treat (ITT) analysis and controls. Excess weight loss was significantly increased by endoluminal mechanical device insertion (18.4, 12.2, and 4.4% in completers, ITT analysis group and controls; p = 0.02 for completers vs. controls). Measuring glucose, insulin, and glucagon-like peptide 1 (GLP-1) following a mixed-meal test with the device in place and after removal (n = 7), the device delayed glucose absorption and insulin secretion and altered kinetics in GLP-1 levels.
The device might be short-term effective in reducing body weight, which might be mediated through alterations in incretin metabolism. However, frequent device migration necessitates device modifications.
腔内机械装置 SatiSphere 是一种新型的内镜可植入装置，旨在延迟营养物质通过十二指肠的转运时间。它由一根 1 毫米的镍钛诺丝制成，两端为猪尾状，并在其沿线安装了几个网球形结构，在十二指肠和胃窦中释放，以符合十二指肠 C 环的形态，从而实现自我固定。
本研究旨在进行一项 2:1 的随机研究，以测试其安全性、疗效和对体重的影响，并进行亚组的肠促胰岛素分泌研究。
31 例患者（11 名男性，平均年龄 42.9 岁，平均 BMI 为 41.3kg/m2）中，21 例接受内镜下装置插入治疗并计划在 3 个月后取出装置，与 10 例对照患者进行比较。在 21 例患者中，有 10 例出现装置迁移，其中 2 例需要紧急手术，导致试验终止。完成治疗的 3 个月后体重减轻分别为 6.7、4.6 和 2.2kg，在按意向治疗（ITT）分析的所有治疗病例和对照组中均如此。腔内机械装置插入后，超重减轻明显增加（完成治疗者、ITT 分析组和对照组分别为 18.4、12.2 和 4.4%；完成治疗者与对照组相比，p=0.02）。在放置和取出装置后进行混合餐测试，测量血糖、胰岛素和胰高血糖素样肽 1（GLP-1）（n=7），发现装置延迟了葡萄糖吸收和胰岛素分泌，并改变了 GLP-1 水平的动力学。
该装置在短期内可能有效减轻体重，这可能是通过改变肠促胰岛素代谢来实现的。然而，频繁的装置迁移需要对装置进行修改。
