Ignite Creation Date:
2024-05-06 @ 3:17 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02258698
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2014-09-29
Brief Title:
Insulin Sensitivity Irisin and Adipokines as Outcome Parameters in Patients Undergoing Cardiac Surgery
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Insulin Sensitivity Irisin and Adipokines as Outcome Parameters in Patients Undergoing Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patientsit 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 005
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 patientsit 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 005
Detailed Description:
see Information below
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None