Clinical trial NCT02258698: Insulin Sensitivity, Irisin and Adipokines as Outcome Parameters in Patients Undergoing Cardiac Surgery
Official title: Insulin Sensitivity, Irisin and Adipokines as Outcome Parameters in Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insulin Resistance
Diabetes Mellitus Type 2
Other Functional Disturbances Following Cardiac Surgery
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: McGill University
First posted: 2014-10-07
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 325 patients admitted to the surgical intensive care unit after elective on-pump cardiac surgery (Table 1) will be consecutively enrolled. This study population has been chosen not only because of the clinically relevant stress response to cardiac surgery but also because of the opportunity to differentiate between the different impacts of the cardiovascular system and the metabolic state on insulin resistance.

Brief summary: 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.

Detailed description: see Information below

Eligibility criteria: 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

Primary outcomes:
measure: Number of adverse outcomes in relation to Insulin resistance measured as HOMA (homeostasis model assessment)
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Number of adverse outcomes in relation to Insulin resistance measured as QUICKI
timeFrame: 30 days after surgery
measure: Number of adverse outcomes in relation to Insulin resistance measured as HbA1c
timeFrame: 30 days after surgery
measure: Number of adverse outcomes in relation to Insulin resistance measured as ANGPTL2
timeFrame: 30 days after surgery
measure: Number of adverse outcomes in relation to Insulin resistance measured as CXCL5
timeFrame: 30 days after surgery
measure: Number of adverse outcomes in relation to Insulin resistance measured as NAMPT
timeFrame: 30 days after surgery
measure: Number of adverse outcomes in relation to Insulin resistance measured as irisin
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Andrea Kopp Lugli
state: BS
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Andrea Kopp Lugli, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: