Stobbe Ayla Y, de Klerk Eline S, van Wilpe Robert, Kievit Arthur J, Choi Kee Fong, Preckel Benedikt, Hollmann Markus W, Hermanides Jeroen, van Stijn Mireille F M, Hulst Abraham H
Department of Anaesthesiology, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands.
Department of Endocrinology, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands.
BMJ Open. 2025 Jan 21;15(1):e087260. doi: 10.1136/bmjopen-2024-087260.
Surgical trauma induces a metabolic stress response, resulting in reduced insulin sensitivity and hyperglycaemia. Postoperative insulin resistance (IR) is associated with postoperative complications, and extended preoperative fasting may further aggravate the postoperative metabolic stress response. Nutritional strategies, such as carbohydrate loading (CHL), have been successfully used to attenuate postoperative IR. Recent evidence suggests that time-restricted feeding (TRF), a form of intermittent fasting, improves IR in the general population, even after a short period of TRF. We hypothesise that TRF, as well as CHL, improve postoperative IR.
This open-label, single-centre, randomised controlled trial will compare the effect of short-term preoperative TRF, CHL and standard preoperative fasting on perioperative IR. A total of 75 orthopaedic patients presenting for elective intermediate to major surgery at a Dutch academic hospital will be randomly assigned to a control group (standard preoperative fasting), a TRF group or a CHL group. The primary outcome is postoperative IR, based on the updated homeostasis model assessment of IR, on the first day after surgery. Statistical analyses are performed using Student's t-tests or Mann-Whitney U tests.
The local medical ethics committee of the Amsterdam UMC, the Netherlands, approved the trial protocol in January 2023 (NL81556.018.22). No publication restrictions apply, and the results of the study will be disseminated through a peer-reviewed journal.
NCT05760339.
手术创伤会引发代谢应激反应，导致胰岛素敏感性降低和血糖升高。术后胰岛素抵抗（IR）与术后并发症相关，而术前禁食时间延长可能会进一步加重术后代谢应激反应。营养策略，如碳水化合物负荷（CHL），已成功用于减轻术后IR。最近的证据表明，限时进食（TRF）作为一种间歇性禁食形式，即使在短时间的TRF后，也能改善普通人群的IR。我们假设TRF以及CHL都能改善术后IR。
这项开放标签、单中心、随机对照试验将比较术前短期TRF、CHL和标准术前禁食对围手术期IR的影响。荷兰一家学术医院的75名择期进行中大型手术的骨科患者将被随机分配到对照组（标准术前禁食）、TRF组或CHL组。主要结局是术后第一天基于更新的IR稳态模型评估的术后IR。使用学生t检验或曼-惠特尼U检验进行统计分析。
荷兰阿姆斯特丹大学医学中心的当地医学伦理委员会于2023年1月批准了试验方案（NL81556.018.22）。没有出版限制，研究结果将通过同行评审期刊进行传播。
NCT05760339。
