Effect of Insulin Resistance Reducing Agents Pre and Post CABG on Post-operative Metabolic Status and Oxidative Stress (ECIRRA)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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%
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Expérimental: 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
|
|
Expérimental: 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
|
|
Comparateur placebo: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Serum glucose
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Body Composition changes
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 91-6447
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