Effect of Insulin Resistance Reducing Agents Pre and Post CABG on Post-operative Metabolic Status and Oxidative Stress (ECIRRA)
調査の概要
状態
条件
詳細な説明
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:
- 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.
研究の種類
入学 (実際)
段階
- フェーズ2
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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%
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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
|
|
実験的：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
|
|
プラセボコンパレーター：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serum glucose
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Body Composition changes
時間枠：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
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。