Andrea Kopp Lugli
Basel, Canton of Basel-City, 4031, Switzerland
NCT Number: NCT02258698
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Basel, Canton of Basel-City, 4031, Switzerland
see Information below
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 30 days after surgery
Time frame: 30 days after surgery
Time frame: 30 days after surgery
Time frame: 30 days after surgery
Time frame: 30 days after surgery
Time frame: 30 days after surgery
Time frame: 30 days after surgery
University Hospital, Basel, Switzerland
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01336777
Body Weight, Diabetes Mellitus
Stanford, California, United States
View Trial DetailsNCT02863276
Diabetes Mellitus, Diabetes Mellitus Type 2
View Trial DetailsNCT01121172
Body Weight, Diabetes Mellitus
Thessaloniki, Greece
View Trial DetailsNCT00401453
Diabetes Mellitus, Diabetes Mellitus Type 2
Mannheim, Baden-Wurttemberg, Germany
View Trial Details