Objective

Randomized controlled trials (RCTs) have demonstrated the superiority of metabolic surgery (MS) over medical therapy (MT) in patients with obesity and type 2 diabetes, leading, to a joint statement in 2016 proposing MS to patients with class I obesity and uncontrolled glycemia. Yet, these RCTs included few patients with class I obesity (body mass index 30–35 kg/m²) and even fewer patients with overweight. Our aim was to provide an updated systematic review (SR) with meta-analysis (MA) of RCTs reporting diabetes remission (DR) after MS in these patients.

Research design and methods

We included in the SR with MA only RCTs with at least 24-month follow-up found in Medline, Cochrane Library, Embase, and LiSSA between January 2008 and September 2022 comparing DR post-MT versus post-MS. We calculated relative risk (RR) and 95 % confidence intervals (CIs) using the Mantel-Haenszel random-effects approach to examine differences in DR between patients allocated to MS versus MT.

Results

DR was significantly higher in MS versus MT after 36 months’ follow-up in patients with obesity (RR = 6.65 [95 %CI 2.24;19.79]; I² = 27 %; 5 trials, 404 patients), but also specifically in patients with class I obesity (RR = 5.27 [1.31;21.23]; I² = 0 %; 4 trials, 80 patients). Furthermore, and in line with previous results, all additional MAs performed in patients with obesity in this work favor MS (specifically Roux-en-Y gastric bypass) over MT at 24, 36 (only) and 60 months of follow-up.

Conclusions

Although the data available in patients with class I obesity and type 2 diabetes remains limited, MA shows higher rates of DR after MS compared with MT after 36 months’ follow-up in these patients. Consequently, the French National Authority for Health French (HAS) recommends MS for these patients.

中文翻译：

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法国国家卫生局对代谢手术缓解 2 型糖尿病的评估——对 I 至 III 级肥胖患者的荟萃分析

客观的

随机对照试验 (RCT) 证明，对于肥胖和 2 型糖尿病患者，代谢手术 (MS) 优于药物治疗 (MT)，因此 2016 年发表联合声明，提议对 I 级肥胖和血糖失控的患者进行 MS 。然而，这些随机对照试验只包括很少的 I 级肥胖患者（体重指数 30-35 kg/m ²），甚至更少的超重患者。我们的目的是通过对报告这些患者 MS 后糖尿病缓解 (DR) 的随机对照试验 (RCT) 进行荟萃分析 (MA)，提供更新的系统评价 (SR)。

研究设计和方法

我们在 SR 和 MA 中纳入了 2008 年 1 月至 2022 年 9 月期间在 Medline、Cochrane 图书馆、Embase 和 LiSSA 中发现的至少进行了 24 个月随访的随机对照试验，比较了 MT 后的 DR 与 MS 后的情况。我们使用 Mantel-Haenszel 随机效应方法计算了相对风险 (RR) 和 95% 置信区间 (CI)，以检查分配到 MS 与 MT 的患者之间 DR 的差异。

结果

肥胖患者 36 个月随访后，MS 的 DR 显着高于 MT（RR = 6.65 [95 % CI 2.24;19.79]；I² = 27 %；5 项试验，404 名患者），而且特别是在肥胖患者中I 级肥胖（RR = 5.27 [1.31;21.23]；I² = 0 %；4 项试验，80 名患者）。此外，与之前的结果一致，在这项工作中对肥胖患者进行的所有其他 MA 在 24、36（仅）和 60 个月的随访中都倾向于 MS（特别是 Roux-en-Y 胃绕道手术）而不是 MT。

结论

尽管 I 级肥胖和 2 型糖尿病患者的可用数据仍然有限，但在这些患者的 36 个月随访后，MA 表明 MS 后 DR 的发生率高于 MT。因此，法国国家卫生局 ( HAS)建议对这些患者进行 MS。