肥胖 2 型糖尿病患者接受 Roux-en-Y 胃旁路手术与强化生活方式管理随机分组 3 年后的临床和以患者为中心的结局：SLIMM-T2D 研究。
Clinical and Patient-Centered Outcomes in Obese Patients With Type 2 Diabetes 3 Years After Randomization to Roux-en-Y Gastric Bypass Surgery Versus Intensive Lifestyle Management: The SLIMM-T2D Study.
机构信息
Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, MA
Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
出版信息
Diabetes Care. 2018 Apr;41(4):670-679. doi: 10.2337/dc17-0487. Epub 2018 Feb 6.
OBJECTIVE
To compare the effect of Roux-en-Y gastric bypass (RYGB) surgery versus intensive medical diabetes and weight management (IMWM) on clinical and patient-reported outcomes in obese patients with type 2 diabetes.
RESEARCH DESIGN AND METHODS
We prospectively randomized 38 obese patients with type 2 diabetes (15 male and 23 female, with mean ± SD weight 104 ± 16 kg, BMI 36.3 ± 3.4 kg/m, age 52 ± 6 years, and HbA 8.5 ± 1.3% [69 ± 14 mmol/mol]) to laparoscopic RYGB ( = 19) or IMWM ( = 19). Changes in weight, HbA, cardiovascular risk factors (UKPDS risk engine), and self-reported health status (the 36-Item Short-Form [SF-36] survey, Impact of Weight on Quality of Life [IWQOL] instrument, and Problem Areas in Diabetes Survey [PAID]) were assessed.
RESULTS
After 3 years, the RYGB group had greater weight loss (mean -24.9 kg [95% CI -29.5, -20.4] vs. -5.2 [-10.3, -0.2]; < 0.001) and lowering of HbA (-1.79% [-2.38, -1.20] vs. -0.39% [-1.06, 0.28] [-19.6 mmol/mol {95% CI -26.0, -13.1} vs. -4.3 {-11.6, 3.1}]; < 0.001) compared with the IMWM group. Changes in cardiometabolic risk for coronary heart disease and stroke were all more favorable in RYGB versus IMWM ( < 0.05 to < 0.01). IWQOL improved more after RYGB ( < 0.001), primarily due to subscales of physical function, self-esteem, and work performance. SF-36 and PAID scores improved in both groups, with no difference between treatments. A structural equation model demonstrated that improvement in overall quality of life was more strongly associated with weight loss than with improved HbA and was manifest by greater improvements in IWQOL than with either SF-36 or PAID.
CONCLUSIONS
Three years after randomization to RYGB versus IMWM, surgery produced greater weight loss, lower HbA, reduced cardiovascular risk, and improvements in obesity-related quality of life in obese patients with type 2 diabetes.
目的
比较 Roux-en-Y 胃旁路手术（RYGB）与强化医学糖尿病和体重管理（IMWM）对肥胖 2 型糖尿病患者的临床和患者报告结局的影响。
研究设计和方法
我们前瞻性随机分配了 38 名肥胖 2 型糖尿病患者（男 15 名，女 23 名，平均 ± 标准差体重 104 ± 16 kg，BMI 36.3 ± 3.4 kg/m²，年龄 52 ± 6 岁，HbA 8.5 ± 1.3%[69 ± 14 mmol/mol]）接受腹腔镜 RYGB（n = 19）或 IMWM（n = 19）。评估体重、HbA、心血管危险因素（UKPDS 风险引擎）和自我报告的健康状况（36-项简短表格 [SF-36] 调查、体重对生活质量的影响 [IWQOL] 量表和糖尿病问题区域调查 [PAID]）的变化。
结果
3 年后，RYGB 组体重减轻更多（平均 -24.9 kg [95% CI -29.5, -20.4] 与 -5.2 [-10.3, -0.2]；< 0.001），HbA 降低更多（-1.79% [-2.38, -1.20] 与 -0.39% [-1.06, 0.28]；[-19.6 mmol/mol{95% CI -26.0, -13.1} 与 -4.3 [-11.6, 3.1]；< 0.001），与 IMWM 组相比。RYGB 与 IMWM 相比，冠心病和中风的心血管风险改善更为有利（< 0.05 至 < 0.01）。RYGB 后 IWQOL 改善更为明显（< 0.001），主要是由于身体功能、自尊和工作表现的亚量表。SF-36 和 PAID 评分在两组均有所改善，治疗之间无差异。结构方程模型表明，整体生活质量的改善与体重减轻的相关性更强，而与 HbA 的改善相关性更弱，且与 SF-36 或 PAID 相比，IWQOL 的改善更为明显。
结论
随机分配至 RYGB 与 IMWM 3 年后，手术在肥胖 2 型糖尿病患者中产生了更大的体重减轻、更低的 HbA、降低的心血管风险和改善与肥胖相关的生活质量。
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