Insulin Sensitivity, Irisin and Adipokines as Outcome Parameters in Patients Undergoing Cardiac Surgery
BACKGROUND: Surgical injury and inflammation provoke a stereotypical stress response. Insulin resistance plays an intriguing role in these metabolic alterations and depends on the intensity of injury. Metabolic derangements resulting from peripheral insulin resistance are unambiguously related to adverse outcomes and higher perioperative complication rates. Therefore, insulin resistance offers to act as a marker for stress and is potentially relevant in predicting clinical outcome. Plasma-glycosylated hemoglobin A (HbA1c) is an established indicator for blood glucose control and has a prognostic value regarding outcomes after major surgical interventions.
Adipose tissue holds a key function in endocrine metabolism by releasing multiple substances, so-called adipose-derived secreted factors or adipokines. Recent studies have linked several adipokines to overall insulin sensitivity in metabolic syndrome-related conditions as well as in critical illness. Irisin, a recently identified myokine acts on white adipose tissue and plays a role in the prevention of insulin resistance.
AIMS OF THE STUDY: The aim of this study is to assess the level and the effects of perioperative insulin resistance on clinical outcome in cardiac surgery patients. Based on previous studies suggesting glucose homeostasis and insulin resistance are associated with severity of illness and outcome in critically ill patients,it is proposed that patients with marked insulin resistance suffer from worse clinical outcome. This study protocol evaluates the ability of homeostasis model assessment (HOMA), quantitative insulin sensitivity check index (QUICKI), HbA1c, the adipokines Angiopoietin-like protein 2 (ANGPTL2), C-X-C motif chemokine 5 (CXCL5), and visfatin, and the myokine irisin to indicate perioperative insulin resistance and explores for correlation with adverse clinical outcomes after 30 days.
MATERIAL & METHODS: 325 patients admitted to the surgical intensive care unit after elective on-pump cardiac surgery will be consecutively enrolled. Baseline characteristics and routine blood samples will be assessed the day before surgery. Study blood samples will be drawn preoperatively in the induction bay of anesthesia to measure the insulin resistance indices HOMA and QUICKI, HbA1c, ANGPTL2, CXCL5, visfatin, and irisin. Blood glucose, irisin, adipokines, and routine biochemical tests will be assessed upon admission to the intensive care unit and on postoperative days 1 and 3. Adverse outcomes will be assessed 30 days after surgery. Sample size is set to ensure at least 80% power at a significance level of 0.05.
調査の概要
詳細な説明
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
BS
-
Basel、BS、スイス、4031
- Andrea Kopp Lugli
-
-
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Aged >18 years
- Admission to the surgical intensive care unit after elective cardiac surgery (aortocoronary bypass and/or valve repair)
- Being capable of understanding and signing the consent form
Exclusion Criteria:
- Blood glucose values requiring continuous insulin infusion preoperatively
- Ongoing selenium therapy
- Pregnancy
- Interventional valve repair
- Intraoperative hypothermic cardiac arrest
- Off-pump cardiac surgery
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Elective on-pump cardiac surgery
Observation of perioperative Insulin resistance in patients undergoing elective on-pump cardiac surgery (CABG and/or valve repair)
|
Blood samples for assessing Insulin resistance by HOMA, QUICKI, HbA1c, ANGPTL2, CXCL5, visfatin and irisin are drawn during induction of anesthesia, upon arrival on the intensive care unit and on postoperative day 1 and 3. Thirty days after surgery adverse outcomes covering all-cause morbidity and mortality will be assessed.
|
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 |
時間枠 |
|---|---|
|
Number of adverse outcomes in relation to Insulin resistance measured as HOMA (homeostasis model assessment)
時間枠:30 days after surgery
|
30 days after surgery
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Number of adverse outcomes in relation to Insulin resistance measured as QUICKI
時間枠:30 days after surgery
|
30 days after surgery
|
|
Number of adverse outcomes in relation to Insulin resistance measured as HbA1c
時間枠:30 days after surgery
|
30 days after surgery
|
|
Number of adverse outcomes in relation to Insulin resistance measured as ANGPTL2
時間枠:30 days after surgery
|
30 days after surgery
|
|
Number of adverse outcomes in relation to Insulin resistance measured as CXCL5
時間枠:30 days after surgery
|
30 days after surgery
|
|
Number of adverse outcomes in relation to Insulin resistance measured as NAMPT
時間枠:30 days after surgery
|
30 days after surgery
|
|
Number of adverse outcomes in relation to Insulin resistance measured as irisin
時間枠:30 days after surgery
|
30 days after surgery
|
協力者と研究者
捜査官
- 主任研究者:Andrea Kopp Lugli, MD, MSc、University Hospital, Basel, Switzerland
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。
Cardiac surgeryの臨床試験
-
Medical University of Viennaまだ募集していません心臓および大動脈手術 | 静脈うっ血 | 輸液蘇生 | 心臓麻酔
-
Bournemouth UniversityStryker Orthopaedics; Nuffield Health Bournemouth; Orthopaedic Research Institute完了
-
Medtronic Cardiac Rhythm and Heart FailureMedtronic International Trading Sarl完了
-
Medtronic Cardiac Ablation Solutions完了
-
Uppsala University HospitalMedtronic; Swedish Heart Lung Foundationわからない
-
St. Luke's-Roosevelt Hospital Center完了
-
Medtronic Cardiac Rhythm and Heart Failure完了