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调整胃束带手术或药物治疗肥胖合并 2 型糖尿病患者:一项随机试验的 3 年结果。

Adjustable gastric band surgery or medical management in patients with type 2 diabetes and obesity: three-year results of a randomized trial.

机构信息

Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

Center for Metabolic and Bariatric Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

出版信息

Surg Obes Relat Dis. 2019 Dec;15(12):2052-2059. doi: 10.1016/j.soard.2019.03.038. Epub 2019 Apr 16.

Abstract

BACKGROUND

Few randomized trials have compared surgical versus lifestyle and pharmacologic approaches for type 2 diabetes (T2D) patients with mild to moderate obesity.

OBJECTIVES

This study examined resolution of hyperglycemia (A1C <6.5% and fasting glucose <126 mg/dL) 3 years after randomization to either a laparoscopic adjustable gastric band (LAGB) or 1-year diabetes and weight management (DWM) program.

SETTING

University medical center, United States.

METHODS

Forty T2D patients (mean ± SD: age, 51.3 ±10.0 yr; weight 109.5 ± 15.0 kg; body mass index [BMI] 36.5 ± 3.7 kg/m; HBA1C 8.2% ± 1.2%) were randomized to LAGB (n = 18) or DWM (n = 22).

RESULTS

At 3 years, 13% of 16 patients in LAGB and 5% of 17 patients in DWM achieved resolution of hyperglycemia (P = .601), with a modestly greater reduction in antidiabetic medications in the surgical group (P = .054). Reductions from baseline in A1C were sustained at 3 years in LAGB (-.82% [95% CI: -1.62 to -.01], P = .046) compared with DWM (+.23% [95% CI: -.57 to 1.03], P = .567). The surgical group had greater weight loss (-12.0 kg [95% CI: -15.9 to -8.1] versus -4.8 [95% CI: -8.6 to -.9], P = .010). HDL-cholesterol increased more after surgery (P = .003), but changes in triglycerides, LDL-cholesterol, and blood pressure did not differ between treatments. Diabetes- and obesity-specific quality of life improved comparably with both therapies.

CONCLUSIONS

Achievement of American Diabetes Association targets for glucose, lipids, and blood pressure was similar with both treatment strategies. LAGB leads to greater sustained weight loss and higher HDL cholesterol compared with a DWM program. These findings may help guide patients with T2D and obesity when exploring options for diabetes and weight management.

摘要

背景

很少有随机试验比较过手术与生活方式和药物治疗方法,用于治疗 2 型糖尿病(T2D)合并轻中度肥胖的患者。

目的

本研究旨在观察随机分组接受腹腔镜可调节胃束带术(LAGB)或为期 1 年的糖尿病和体重管理(DWM)计划治疗 3 年后,患者的高血糖(A1C<6.5%和空腹血糖<126mg/dL)是否得到缓解。

设置

美国一所大学医学中心。

方法

40 例 T2D 患者(平均±标准差:年龄 51.3±10.0 岁;体重 109.5±15.0kg;体重指数(BMI)36.5±3.7kg/m;HBA1C 8.2%±1.2%)被随机分配至 LAGB 组(n=18)或 DWM 组(n=22)。

结果

3 年后,LAGB 组 16 例患者中有 13%(16/121)、DWM 组 17 例患者中有 5%(17/343)达到高血糖缓解(P=.601),手术组抗糖尿病药物的使用量有适度减少(P=.054)。LAGB 组的 A1C 从基线水平的降低在 3 年内保持稳定(-0.82%[95%CI:-1.62 至 -.01],P=.046),而 DWM 组则有所升高(+0.23%[95%CI:-.57 至 1.03],P=.567)。手术组体重减轻更多(-12.0kg[95%CI:-15.9 至 -8.1] 与 -4.8kg[95%CI:-8.6 至 -.9],P=.010)。手术后 HDL-胆固醇增加更多(P=.003),但两种治疗方法在甘油三酯、LDL-胆固醇和血压方面的变化没有差异。糖尿病和肥胖特异性生活质量均与两种治疗方法同样得到改善。

结论

两种治疗策略在血糖、血脂和血压方面达到美国糖尿病协会目标的情况相似。与 DWM 方案相比,LAGB 可导致更持续的体重减轻和更高的 HDL 胆固醇。这些发现可能有助于指导 T2D 合并肥胖的患者在探索糖尿病和体重管理的选择时提供参考。

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