Center of Excellence of Metabolic and Bariatric Surgery, Hospital Oswaldo Cruz, Rua Padre Joao Manuel 222 CJ 131, São Paulo-SP, Brasil 04002-020.
J Clin Endocrinol Metab. 2013 Feb;98(2):E279-82. doi: 10.1210/jc.2012-2814. Epub 2013 Jan 21.
The duodenal-jejunal bypass liner (DJBL) is a device that mimics the intestinal portion of gastric bypass surgery and has been shown to improve glucose metabolism rapidly in obese subjects with type 2 diabetes (T2DM).
To assess the safety of the DJBL and to evaluate its potential to affect glycemic control beneficially in subjects with T2DM who were not morbidly obese.
Adult men and women with T2DM of ≤ 10 years' duration with hemoglobin A1c (HbA1c) ≥ 7.5% and ≤ 10% and having a body mass index ≥ 26 to ≤ 50 kg/m(2) were enrolled in this prospective, 52-week, single-center, open-label clinical study.
Adverse events and changes in body weight, fasting plasma glucose (FPG) levels, and HbA1c levels.
Sixteen of 20 subjects implanted with the DJBL completed the 1-year study (mean body mass index = 30.0 ± 3.6, mean ± SD). Gastrointestinal disorders were reported by 13 subjects, and metabolic or nutritional disorders occurred in 14 subjects. FPG levels dropped from 207 ± 61 mg/dL at baseline to 139 ± 37 mg/dL at 1 week and remained low throughout the study. Mean body weight also declined, but the change in body weight was not significantly associated with change in FPG at 52 weeks. HbA1c declined from 8.7 ± 0.9% at baseline to 7.5 ± 1.6% at week 52.
The improvements in glycemic status were observed at 1 year in moderately obese subjects with T2DM, suggesting that the DJBL may represent an effective adjuvant to standard medical therapy of T2DM in this population.
十二指肠空肠旁路管（DJBL）是一种模仿胃旁路手术肠道部分的装置，已被证明可快速改善肥胖 2 型糖尿病（T2DM）患者的葡萄糖代谢。
评估 DJBL 的安全性，并评估其对非病态肥胖的 T2DM 患者血糖控制产生有益影响的潜力。
这项前瞻性、52 周、单中心、开放标签临床研究纳入了病程≤10 年、糖化血红蛋白（HbA1c）≥7.5%且≤10%、体重指数（BMI）≥26 至≤50kg/m²的成年男性和女性 T2DM 患者。
不良事件以及体重、空腹血糖（FPG）水平和 HbA1c 水平的变化。
20 例植入 DJBL 的患者中，有 16 例完成了 1 年的研究（平均 BMI=30.0±3.6，均数±标准差）。13 例患者报告有胃肠道疾病，14 例患者发生代谢或营养紊乱。FPG 水平从基线时的 207±61mg/dL 下降至 1 周时的 139±37mg/dL，并在整个研究期间保持较低水平。平均体重也下降，但 52 周时体重变化与 FPG 变化无显著相关性。HbA1c 从基线时的 8.7±0.9%下降至 52 周时的 7.5±1.6%。
在肥胖程度适中的 T2DM 患者中，观察到 1 年时血糖状态得到改善，提示 DJBL 可能成为该人群中 T2DM 标准药物治疗的有效辅助手段。
