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

2014年10月23日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

92

阶段

  • 阶段2

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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%

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
实验性的: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
实验性的: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
安慰剂比较: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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Serum glucose
大体时间: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
大体时间: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
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Body Composition changes
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年6月1日

初级完成 (实际的)

2014年3月1日

研究完成 (实际的)

2014年7月1日

研究注册日期

首次提交

2014年7月3日

首先提交符合 QC 标准的

2014年7月8日

首次发布 (估计)

2014年7月9日

研究记录更新

最后更新发布 (估计)

2014年10月24日

上次提交的符合 QC 标准的更新

2014年10月23日

最后验证

2014年10月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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