无钉合与钉合胃旁路术与低热量饮食：一项关于体重演变的三臂随机对照试验，次要结局为端粒长度和代谢综合征变化。

Stapleless vs Stapled Gastric Bypass vs Hypocaloric Diet: a Three-Arm Randomized Controlled Trial of Body Mass Evolution with Secondary Outcomes for Telomere Length and Metabolic Syndrome Changes.

机构信息

Research Group of the University Medical Center, Nur-Sultan, Kazakhstan.

Department of Surgical Diseases and Bariatric Surgery, Astana Medical University, Nur-Sultan, Kazakhstan.

出版信息

Obes Surg. 2021 Jul;31(7):3165-3176. doi: 10.1007/s11695-021-05454-2. Epub 2021 May 8.

DOI:10.1007/s11695-021-05454-2

PMID:33963974

Abstract

BACKGROUND

Obesity and metabolic syndrome (MetS) reduce life expectancy and are challenging to resolve. This randomized controlled trial (RCT) of patients with obesity and MetS undergoing surgical vs nonsurgical treatment compared changes in BMI, and secondarily, telomere length (as a biomarker of life expectancy) and changes in MetS components (insulin resistance, dyslipidemia, hypertension).

METHODS

Study design was a single-center, prospective, three-arm RCT. Group 1 patients underwent novel unstapled laparoscopic one anastomosis gastric bypass with an obstructive stapleless pouch and anastomosis (LOAGB-OSPAN); Group 2, stapled laparoscopic mini-gastric bypass-one anastomosis gastric bypass (LMGB-OAGB); and Group 3, nonsurgical weight loss therapy via a hypocaloric diet with energy restriction (HDER). The primary outcome measure was change in BMI; secondary outcome measures included change in leukocyte telomere length and other MetS components.

RESULTS

Of 96 participants screened, 60 were randomly allocated to 3 groups: LOAGB-OSPAN group (n = 20), LMGB-OAGB group (n = 20), and HDER group (n = 20). At post-treatment month 12, respective BMI changes: BMI -12.13 (-8.34, -15.93); -16.04 (-11.7, 20.37); -2,76 (-3.84, -9.36) (p < 0.01). The two surgical groups experienced significant change in telomere length: LOAGB-OSPAN 2.02 (1.61, 2.41), p = 0.001; LMGB-OAGB 2.07 (1.72, 2.43), p = 0.001; and HDER 0.28 (0.22, 0.78), p = 0.26. The surgical groups were also more effective in treating MetS components. There were no deaths. Adverse events: LOAGB-OSPAN (n = 2) (Clavien-Dindo grade II); LMGB-OAGB (n = 8) (grade I (n = 6) and grade II (n = 2).

CONCLUSIONS

Compared with hypocaloric diet therapy, both bariatric procedures resulted in greater BMI loss, and secondarily, a significant increase in telomere length, and greater MetS resolution.

TRIAL REGISTRATION

ClinicalTrials.gov , NCT03667469, registered on 11 September 2018.

摘要

背景

肥胖和代谢综合征（MetS）会降低预期寿命，且难以解决。这项针对肥胖和 MetS 患者进行手术与非手术治疗的随机对照试验（RCT）比较了 BMI 的变化，其次是端粒长度（作为预期寿命的生物标志物）和 MetS 成分（胰岛素抵抗、血脂异常、高血压）的变化。

方法

研究设计为单中心、前瞻性、三臂 RCT。第 1 组患者接受新型无钉腹腔镜单吻合口胃旁路术（LOAGB-OSPAN），具有非阻塞性无钉袋和吻合口；第 2 组接受腹腔镜迷你胃旁路-单吻合口胃旁路术（LMGB-OAGB）；第 3 组接受低热量饮食限制能量的非手术减肥治疗（HDER）。主要结局测量指标为 BMI 的变化；次要结局指标包括白细胞端粒长度和其他 MetS 成分的变化。

结果

在筛选的 96 名参与者中，有 60 名被随机分配到 3 组：LOAGB-OSPAN 组（n = 20）、LMGB-OAGB 组（n = 20）和 HDER 组（n = 20）。治疗后 12 个月时，BMI 的变化分别为：BMI -12.13（-8.34，-15.93）；-16.04（-11.7，20.37）；-2.76（-3.84，-9.36）（p < 0.01）。两个手术组的端粒长度均发生显著变化：LOAGB-OSPAN 2.02（1.61，2.41），p = 0.001；LMGB-OAGB 2.07（1.72，2.43），p = 0.001；和 HDER 0.28（0.22，0.78），p = 0.26。手术组在治疗 MetS 成分方面也更有效。无死亡事件。不良事件：LOAGB-OSPAN（n = 2）（Clavien-Dindo 分级 II）；LMGB-OAGB（n = 8）（I 级（n = 6）和 II 级（n = 2））。