Effect of Insulin Resistance Reducing Agents Pre and Post CABG on Post-operative Metabolic Status and Oxidative Stress (ECIRRA)
Studieoversikt
Status
Forhold
Detaljert 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:
- 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
- Consumption of placebo 7 days before surgery and supplement 30 days post surgery
- Consumption of the supplement 7 days before and 30 days post surgery
- 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.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Supplement pre CABG
Consumption of the supplement 7 days before surgery and placebo 30 days post surgery
|
One sachet of the supplement was consumed daily for 7 days before surgery.
|
|
Eksperimentell: Supplement post CABG
Consumption of placebo 7 days before surgery and supplement 30 days post surgery
|
One sachet of the supplement was consumed daily for 30 days after surgery
|
|
Eksperimentell: Supplement pre and post CABG
Consumption of the supplement 7 days before and 30 days post surgery
|
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
|
One sachet of placebo was consumed daily for 7 days before surgery and 30 days after CABG
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 91-6447
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