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临床试验/NCT05023499
NCT05023499已完成不适用

Perioperative Glutamine Supplementation Restores Atrophy of Psoas Muscle in Gastric Adenocarcinoma Patients Undergoing Gastrectomy

National Taiwan University Hospital0 个研究点目标入组 550 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
550
主要终点
area psoas major muscle (PMMA; cm2)

研究概览

简要总结

Background Sarcopenia is characterized by the degenerative loss of skeletal muscle and is associated with increased adverse surgical outcomes. Glutamine is considered as an immune-modulating formula, which may stimulate protein synthesis in the skeletal muscle but also inhibited protein-degradation. In this study, the investigators calculate the area and volume psoas major muscle (PMMA; PMMV) of the third lumbar vertebral body as the reference of skeletal muscle. The aim of this study is to investigate whether perioperative glutamine supplementation restores atrophy of psoas muscle.

详细描述

A total of 550 gastric adenocarcinoma (GA) patients undergoing gastrectomy were enrolled for the study. Computed tomography was used to assess the short axis of the psoas muscle, and the change was calculated between preoperative day and three months after gastrectomy. Perioperative glutamine supplementation (PGS) was defined as the subjects with five-day parenteral plus one-month oral use. A linear regression model was performed to predict this association by adjusting clinic-demographics and nutritional calories.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • gastric cancer patients undergoing gastrectomy

排除标准

  • hepatic or renal failures

研究组 & 干预措施

With glutamine supplementation

perioperative glutamine supplementation (PGS) was defined as the subjects with five-day parenteral plus one-month oral use.

干预措施: SYMPT-X Glutamine, Oral Powder for Reconstitution (Drug)

Without glutamine supplementation

no glutamine use

干预措施: SYMPT-X Glutamine, Oral Powder for Reconstitution (Drug)

结局指标

主要结局

area psoas major muscle (PMMA; cm2)

时间窗: 3 month after surgery

We hypothesized that glutamine might play a role in improving sarcopenia. Both the PMMA and total volume of the psoas major muscle (PMMV) represent the severity of sarcopenia, because CT is routinely performed in surgical GA patients to check for cancer recurrence. The reason of including total volume into analysis is that it is considered a better index to define sarcopenia. \[21\] The primary and secondary endpoints were the perioperative change of PMMA and PMMV, respectively.

volume of psoas major muscle (PMMV; cm3)

时间窗: 3 month after surgery

We hypothesized that glutamine might play a role in improving sarcopenia. Both the PMMA and total volume of the psoas major muscle (PMMV) represent the severity of sarcopenia, because CT is routinely performed in surgical GA patients to check for cancer recurrence. The reason of including total volume into analysis is that it is considered a better index to define sarcopenia. \[21\] The primary and secondary endpoints were the perioperative change of PMMA and PMMV, respectively.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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