Department of General Surgery, Khoo Teck Puat Hospital, Singapore; Clinical Research Unit, Khoo Teck Puat Hospital, Singapore.
Diabetes Centre, Admiralty Medical Centre, Khoo Teck Puat Hospital, Singapore.
Diabetes Res Clin Pract. 2022 Jun;188:109900. doi: 10.1016/j.diabres.2022.109900. Epub 2022 May 2.
To evaluate the effects of Roux-en-Y gastric bypass (RYGB) versus best medical treatment in Asians with type 2 diabetes mellitus (T2DM) and class I obesity.
In this 5-year single-centre, open-label randomized controlled trial, participants were randomized to RYGB or medical treatment including newer classes of diabetes medications (ClinicalTrials.gov:NCT02041234). The primary endpoint was diabetes remission defined as HbA1c ≤ 6% (≤42 mmol/mol) and discontinuation of glucose-lowering medication at 12 months post-intervention and beyond. Glycaemia and weight changes were assessed. Continuous glucose monitoring was performed.
Of 28 subjects randomized, 26 were analyzed in the final cohort (14 medical, 12 RYGB; age:44 ± 10 years, 34.6% males, BMI:29.4 ± 1.6 kg/m). At 12 months, 50% of RYGB subjects achieved diabetes remission; 83% stopped all glucose-lowering medications. By year 5, 42% were in remission. None attained diabetes remission in the medical group. Percentage declines in fasting plasma glucose, HbA1c and BMI were significantly greater in the RYGB arm (all P < 0.05). Early improvements in glycaemic variability and time in range were similar in both treatment arms. Hypoglycaemia and surgical complications were observed in some RYGB subjects.
Over 5 years, RYGB outperforms best medical treatment in glycemia and weight improvements for Asians with T2DM and class I obesity.
评估 Roux-en-Y 胃旁路术（RYGB）与最佳药物治疗在亚洲 2 型糖尿病（T2DM）和 I 级肥胖患者中的疗效。
这是一项为期 5 年的单中心、开放标签随机对照试验，参与者被随机分为 RYGB 组或药物治疗组，包括新型糖尿病药物（ClinicalTrials.gov：NCT02041234）。主要终点为糖尿病缓解，定义为干预后 12 个月及以后 HbA1c≤6%（≤42mmol/mol）且停用降糖药物。评估血糖和体重变化。进行连续血糖监测。
28 名受试者随机分组，最终分析了 26 名受试者（14 名药物治疗，12 名 RYGB；年龄：44±10 岁，34.6%为男性，BMI：29.4±1.6kg/m²）。12 个月时，50%的 RYGB 组受试者达到糖尿病缓解；83%停止所有降糖药物。第 5 年时，42%的患者仍处于缓解状态。药物治疗组无患者达到糖尿病缓解。RYGB 组空腹血糖、HbA1c 和 BMI 的百分比下降均显著大于药物治疗组（均 P<0.05）。两组治疗早期的血糖变异性和达标时间改善相似。RYGB 组部分患者出现低血糖和手术并发症。
在 5 年期间，RYGB 在亚洲 T2DM 和 I 级肥胖患者的血糖和体重改善方面优于最佳药物治疗。
