Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Effect of Insulin Resistance Reducing Agents Pre and Post CABG on Post-operative Metabolic Status and Oxidative Stress (ECIRRA)

23. oktober 2014 opdateret af: Mohammad Hassan Eftekhari
The present study aimed to evaluate the effect of a combination of insulin resistance reducing agents pre and post coronary artery bypass grafting surgery on post-operative blood glucose and oxidative stress regulation.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The present study aimed to evaluate the effect of a combination of insulin resistance reducing agents pre and post coronary artery bypass grafting surgery on post-operative blood glucose and oxidative stress regulation. The sample size was estimated to be 92 (23 in each group). The participants of the study were selected from the non-diabetic patients scheduled for CABG. The patients were allocated to four groups using balanced block randomization method:

  1. Consumption of the supplement (a 20 gram pack of the supplement daily) 7 days before surgery and placebo (a pack of starch) 30 days post surgery
  2. Consumption of placebo 7 days before surgery and supplement 30 days post surgery
  3. Consumption of the supplement 7 days before and 30 days post surgery
  4. Consumption of placebo 7 days before and 30 days post surgery One week before, before the onset of the surgery, after the surgery, 1 week after and 4 weeks after the operation, blood samples were taken and the levels of hemoglobin A1C, glucose, insulin and malondialdehyde were measured. Also, body composition indices were assessed in four times: one week before the surgery, before the onset of the surgery, 1 week after and 4 weeks after the surgery.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

92

Fase

  • Fase 2

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

30 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Mean age of 30-70 years old, Having Coronary Artery Disease
  • Undergoing coronary artery bypass grafting surgery

Exclusion Criteria:

  • Positive history of diabetes mellitus, metabolic, hematological, and immune disorders, renal problem, and cerebrovascular accident
  • Taking antioxidant supplements
  • Cases for emergency operations
  • Ejection Fraction < 30%

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Supplement pre CABG
Consumption of the supplement 7 days before surgery and placebo 30 days post surgery
Kosttilskud: Supplement pre CABG
One sachet of the supplement was consumed daily for 7 days before surgery.
Eksperimentel: Supplement post CABG
Consumption of placebo 7 days before surgery and supplement 30 days post surgery
Kosttilskud: Supplement post CABG
One sachet of the supplement was consumed daily for 30 days after surgery
Eksperimentel: Supplement pre and post CABG
Consumption of the supplement 7 days before and 30 days post surgery
Kosttilskud: Supplement pre and post CABG
One sachet of the supplement was consumed daily for 7 days before surgery and 30 days after CABG
Placebo komparator: Placebo
Consumption of placebo 7 days before and 30 days post surgery
Medicin: Placebo
One sachet of placebo was consumed daily for 7 days before surgery and 30 days after CABG

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serum glucose
Tidsramme: 37days

It was measured in 5 steps:

1 week before the operation, Just before the operation, After operation, 1 week post operation, 30 days post operation
37days
serum insulin
Tidsramme: 37 days

It was measured in 5 steps:

1 week before the operation, Just before the operation, After operation, 1 week post operation, 30 days post operation
37 days
Hemoglobin A1C
Tidsramme: 37 days

It was measured in 4 steps:

1 week before the operation, Just before the operation, 1 week post operation, 30 days post operation
37 days
Insulin Resistance
Tidsramme: 37 days

Calculated by HOMA calculation equation

It was calculated in 5 steps:

1 week before the operation, Just before the operation, After operation, 1 week post operation, 30 days post operation
37 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body Composition changes
Tidsramme: 37 days

It was measured in 4 steps:

1 week before the operation, Just before the operation, 1 week post operation, 30 days post operation
37 days
malondialdehyde
Tidsramme: 37 days

It was measured in 5 steps:

1 week before the operation, Just before the operation, After operation, 1 week post operation, 30 days post operation
37 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mohammad Hassan Eftekhari

Samarbejdspartnere

Shiraz University of Medical Sciences

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

1. juni 2013

Primær færdiggørelse (Faktiske)

1. marts 2014

Studieafslutning (Faktiske)

1. juli 2014

Datoer for studieregistrering

Først indsendt

3. juli 2014

Først indsendt, der opfyldte QC-kriterier

8. juli 2014

Først opslået (Skøn)

9. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. oktober 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. oktober 2014

Sidst verificeret

1. oktober 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 91-6447

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Koronararteriesygdom

Kliniske forsøg med Supplement pre CABG

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Saudi Arabia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner