Ding Su-Ann, Simonson Donald C, Wewalka Marlene, Halperin Florencia, Foster Kathleen, Goebel-Fabbri Ann, Hamdy Osama, Clancy Kerri, Lautz David, Vernon Ashley, Goldfine Allison B
Harvard Medical School (S.D., D.C.S., M.W., F.H., A.G.-F., O.H., D.L., A.V., A.B.G.), Boston, Massachusetts 02115; Joslin Diabetes Center (S.D., M.W., F.H., K.F., A.G.-F., O.H., A.B.G.), Boston, Massachusetts 02215; and Brigham and Women's Hospital (D.C.S., F.H., K.C., D.L., A.V., A.B.G.), Boston, Massachusetts 02115.
J Clin Endocrinol Metab. 2015 Jul;100(7):2546-56. doi: 10.1210/jc.2015-1443. Epub 2015 Apr 24.
Recommendations for surgical, compared with lifestyle and pharmacologically based, approaches for type 2 diabetes (T2D) management remain controversial.
The objective was to compare laparoscopic adjustable gastric band (LAGB) to an intensive medical diabetes and weight management (IMWM) program for T2D.
This was designed as a prospective, randomized clinical trial.
The setting was two Harvard Medical School-affiliated academic institutions. INTERVENTIONS AND PARTICIPANTS: A 12-month randomized trial comparing LAGB (n = 23) vs IMWM (n = 22) in persons aged 21-65 years with body mass index of 30-45 kg/m(2), T2D diagnosed more than 1 year earlier, and glycated hemoglobin (HbA(1c)) ≥ 6.5% on antihyperglycemic medication(s).
The proportion meeting the prespecified primary glycemic endpoint, defined as HbA(1c) < 6.5% and fasting glucose < 7.0 mmol/L at 12 months, on or off medication.
After randomization, five participants did not undergo the surgical intervention. Of the 40 initiating intervention (22 males/18 females; age, 51 ± 10 y; body mass index, 36.5 ± 3.7 kg/m(2); diabetes duration, 9 ± 5 y; HbA(1c), 8.2 ± 1.2%; 40% on insulin), the proportion meeting the primary glycemic endpoint was achieved in 33% of the LAGB patients and 23% of the IMWM patients (P = .457). HbA(1c) reduction was similar between groups at both 3 and 12 months (-1.2 ± 0.3 vs -1.0 ± 0.3%; P = .496). Weight loss was similar at 3 months but greater 12 months after LAGB (-13.5 ± 1.7 vs -8.5 ± 1.6 kg; P = .027). Systolic blood pressure reduction was greater after IMWM than LAGB, whereas changes in diastolic blood pressure, lipids, fitness, and cardiovascular risk scores were similar between groups. Patient-reported health status, assessed using the Short Form-36, Impact of Weight on Quality of Life, and Problem Areas in Diabetes, all improved similarly between groups.
LAGB and a multidisciplinary IMWM program have similar 1-year benefits on diabetes control, cardiometabolic risk, and patient satisfaction, which should be considered in the context of other factors, such as personal preference, when selecting treatment options with obese T2D patients. Longer duration studies are important to understand emergent differences.
与基于生活方式和药物治疗的方法相比，手术治疗2型糖尿病（T2D）的建议仍存在争议。
比较腹腔镜可调节胃束带术（LAGB）与强化药物糖尿病和体重管理（IMWM）方案治疗T2D的效果。
这是一项前瞻性随机临床试验。
两个隶属于哈佛医学院的学术机构。
一项为期12个月的随机试验，比较LAGB组（n = 23）和IMWM组（n = 22），参与者年龄在21 - 65岁之间，体重指数为30 - 45kg/m²，T2D诊断时间超过1年，且使用抗高血糖药物时糖化血红蛋白（HbA1c）≥6.5%。
达到预先设定的主要血糖终点的比例，定义为12个月时HbA1c < 6.5%且空腹血糖 < 7.0mmol/L，无论是否用药。
随机分组后，5名参与者未接受手术干预。在40名开始干预的参与者中（22名男性/18名女性；年龄，51±10岁；体重指数，36.5±3.7kg/m²；糖尿病病程，9±5年；HbA1c，8.2±1.2%；40%使用胰岛素），LAGB组33%的患者和IMWM组23%的患者达到了主要血糖终点（P = 0.457）。3个月和12个月时两组的HbA1c降低情况相似（-1.2±0.3 vs -1.0±0.3%；P = 0.496）。3个月时体重减轻情况相似，但LAGB术后12个月体重减轻更多（-13.5±1.7 vs -8.5±1.6kg；P = 0.027）。IMWM组收缩压降低幅度大于LAGB组，而两组间舒张压、血脂、体能和心血管风险评分的变化相似。使用简短健康调查问卷-36、体重对生活质量的影响以及糖尿病问题领域评估的患者报告健康状况，两组改善情况相似。
LAGB和多学科IMWM方案在糖尿病控制、心脏代谢风险和患者满意度方面具有相似的1年益处，在为肥胖T₂D患者选择治疗方案时，应结合其他因素，如个人偏好等进行考虑。进行更长时间的研究对于了解出现的差异很重要。
