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Perioperative Glutamine Supplementation and Cachexia

20. august 2021 opdateret af: National Taiwan University Hospital

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

550

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

  • gastric cancer patients undergoing gastrectomy

Exclusion Criteria:

  • hepatic or renal failures

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
With glutamine supplementation
perioperative glutamine supplementation (PGS) was defined as the subjects with five-day parenteral plus one-month oral use.
Medicin: SYMPT-X Glutamine, Oral Powder for Reconstitution
erioperative glutamine supplementation (PGS) was defined as the subjects with five-day parenteral plus one-month oral use.
Andre navne:
  • SYMPT-X
Without glutamine supplementation
no glutamine use
Medicin: SYMPT-X Glutamine, Oral Powder for Reconstitution
erioperative glutamine supplementation (PGS) was defined as the subjects with five-day parenteral plus one-month oral use.
Andre navne:
  • SYMPT-X

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
area psoas major muscle (PMMA; cm2)
Tidsramme: 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.
3 month after surgery
volume of psoas major muscle (PMMV; cm3)
Tidsramme: 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.
3 month after surgery

Samarbejdspartnere og efterforskere

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Sponsor

National Taiwan University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2016

Primær færdiggørelse (Faktiske)

30. juni 2019

Studieafslutning (Faktiske)

14. august 2021

Datoer for studieregistrering

Først indsendt

15. august 2021

Først indsendt, der opfyldte QC-kriterier

20. august 2021

Først opslået (Faktiske)

26. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 201909033RIND

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

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Kliniske forsøg med Kakeksi

Kliniske forsøg med SYMPT-X Glutamine, Oral Powder for Reconstitution

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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