Department of Digestive Surgery, School of Medicine, Pontificia Universidad Católica, Santiago, Chile,
Surg Endosc. 2014 Apr;28(4):1056-62. doi: 10.1007/s00464-013-3283-y. Epub 2013 Nov 7.
Endoscopic treatment with the duodenal-jejunal bypass liner (DJBL) leads to significant weight loss in obese patients. We sought to identify clinical factors associated with weight loss in obese patients treated with the DJBL for 1 year.
Subjects with morbid obesity were enrolled in a single-arm, open-label, prospective trial and implanted with the DJBL. Patient demographics along with baseline comorbidities, anthropometrics, and biochemical variables were selected for univariate and multivariate analysis.
The DJBL was implanted in 79 subjects and 61 completed 12 months of follow-up. There were 18 early removals. Baseline mean age and body mass index (BMI) were 35.4 ± 9.7 years and 43 ± 5.6 kg/m(2), respectively. Forty-four (72 %) were women. This population included 22 subjects with type 2 diabetes (T2DM). Twelve months after treatment, patients had a mean excess body weight loss (%EBWL) of 46 ± 18 %. Univariate analysis identified that fasting glycemia (r (2) = -0.303, p < 0.013), insulin-resistance determined by HOMA-IR (r (2) = -0.457, p < 0.019), and glycated hemoglobin (HbA1c) (r (2) = -0.471, p < 0.013) were associated inversely with %EBWL at 1 year. In this cohort of patients, the multivariate analysis indicated that only baseline HbA1c levels were associated inversely with %EBWL after 1 year of treatment (β adjusted coefficient -0.758, p < 0.016). Importantly, no differences at 1 year in %EBWL were observed between patients with or without T2DM (%EBWL T2D 46.7 ± 20 % vs. non-T2DM 46.8 ± 18.6 %, p = 0.988).
This analysis indicates that higher baseline HbA1c levels are associated independently with diminished body weight loss in obese patients treated with the DJBL independent of their diabetic status. These results show that DJBL induces clinically significant weight loss in both T2DM and non-T2DM patients.
经十二指肠空肠旁路管（DJBL）进行内镜治疗可使肥胖患者显著减重。本研究旨在确定肥胖患者接受 DJBL 治疗 1 年后与减重相关的临床因素。
招募患有病态肥胖的患者，进行单臂、开放标签、前瞻性试验，并植入 DJBL。选择患者的人口统计学数据以及基线合并症、人体测量学和生化变量进行单变量和多变量分析。
DJBL 共植入 79 例患者，61 例完成 12 个月随访。有 18 例早期移除。基线平均年龄和体重指数（BMI）分别为 35.4 ± 9.7 岁和 43 ± 5.6 kg/m²。44 例（72%）为女性。该人群包括 22 例 2 型糖尿病（T2DM）患者。治疗 12 个月后，患者的平均超重体重减轻率（%EBWL）为 46 ± 18%。单变量分析确定空腹血糖（r²= -0.303，p < 0.013）、通过 HOMA-IR 确定的胰岛素抵抗（r²= -0.457，p < 0.019）和糖化血红蛋白（HbA1c）（r²= -0.471，p < 0.013）与 1 年后的%EBWL 呈负相关。在该患者队列中，多变量分析表明，仅基线 HbA1c 水平与治疗 1 年后的%EBWL 呈负相关（β 调整系数 -0.758，p < 0.016）。重要的是，1 年后，T2DM 患者和非 T2DM 患者的%EBWL 无差异（T2DM 患者的%EBWL 为 46.7 ± 20%，而非 T2DM 患者为 46.8 ± 18.6%，p = 0.988）。
本分析表明，基线 HbA1c 水平较高与接受 DJBL 治疗的肥胖患者的体重减轻程度独立相关，而与糖尿病状态无关。这些结果表明，DJBL 可使 T2DM 和非 T2DM 患者的体重均有临床意义的减轻。
