Department of Mathematics, University Siegen, Emmy-Noether-Campus, Walter-Flex-Str. 3, 57072, Siegen, Germany.
Department of Visceral, Bariatric, and Metabolic Surgery, Klinikum Siegen, Weidenauer Str. 76, 57076, Siegen, Germany.
Obes Surg. 2024 Nov;34(11):4106-4115. doi: 10.1007/s11695-024-07526-5. Epub 2024 Oct 7.
Metabolic and bariatric surgery (MBS) is often considered to be associated with macro- and micronutrient deficiency. A possible treatment option can be the implementation of pancreatic enzyme replacement (PERT) and may lead to better outcomes. We designed a prospective trial investigating the possible impact of PERT in patients undergoing MBS at a high-volume center.
A prospective two-arm randomized controlled trial was conducted on patients who underwent either sleeve gastrectomy or gastric bypass procedures at a high-volume center. Patients underwent bariatric surgery and follow-up examinations at 3, 6, and 12 months after surgery. Patients were stratified either to the treatment group with PERT or to the control group. The primary endpoint of the study was a change in BMI. Lab testing was carried out to measure secondary endpoints, including albumin and vitamin D levels.
Overall, 204 patients were enrolled. Due to missing follow-ups, surgical complications, and side effects due to Kreon medication, 65 were excluded. Analysis of primary endpoints indicates that PERT does not lead to slower weight loss or BMI reduction. Analysis of secondary endpoints showed significantly better vitamin D levels in patients undergoing MBS and PERT. No statistical difference was seen regarding albumin. In both arms, fatty liver disease improved. Quality of life is positively judged as comparable by patients in both groups.
Herein, we show an association between PERT and higher vitamin D levels in patients undergoing MBS. An optimized enzymatic environment due to PERT may therefore result in higher vitamin D levels and may improve clinical outcomes in patients undergoing MBS.
代谢和减重手术（MBS）通常被认为与宏量和微量营养素缺乏有关。一种可能的治疗选择是实施胰酶替代（PERT），这可能会带来更好的结果。我们设计了一项前瞻性试验，以调查高容量中心接受 MBS 的患者中 PERT 的可能影响。
在高容量中心对接受袖状胃切除术或胃旁路手术的患者进行了前瞻性的双臂随机对照试验。患者在手术后 3、6 和 12 个月接受减重手术和随访检查。患者分层为 PERT 治疗组或对照组。该研究的主要终点是 BMI 的变化。进行实验室检测以测量次要终点，包括白蛋白和维生素 D 水平。
共有 204 名患者入组。由于随访丢失、手术并发症和 Creon 药物的副作用，有 65 名患者被排除在外。主要终点分析表明，PERT 不会导致体重减轻或 BMI 降低更慢。对次要终点的分析表明，接受 MBS 和 PERT 的患者的维生素 D 水平显著提高。白蛋白没有统计学差异。在两个臂中，脂肪肝均有所改善。患者对两组的生活质量均评价为相似。
在此，我们显示了接受 MBS 的患者中 PERT 与更高的维生素 D 水平之间存在关联。由于 PERT 优化了酶环境，因此可能会导致更高的维生素 D 水平，并可能改善接受 MBS 的患者的临床结果。
