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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02258698
Date of registration: 29/09/2014
Prospective Registration: No
Primary sponsor: University Hospital, Basel, Switzerland
Public title: Insulin Sensitivity, Irisin and Adipokines as Outcome Parameters in Patients Undergoing Cardiac Surgery
Scientific title: Insulin Sensitivity, Irisin and Adipokines as Outcome Parameters in Patients Undergoing Cardiac Surgery
Date of first enrolment: May 2013
Target sample size: 348
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02258698
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Switzerland
Contacts
Name:     Andrea Kopp Lugli, MD, MSc
Address: 
Telephone:
Email:
Affiliation:  University Hospital, Basel, Switzerland
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Other Functional Disturbances Following Cardiac Surgery
Diabetes Mellitus Type 2
Insulin Resistance
Intervention(s)
Procedure: Cardiac surgery
Primary Outcome(s)
Number of adverse outcomes in relation to Insulin resistance measured as HOMA (homeostasis model assessment) [Time Frame: 30 days after surgery]
Secondary Outcome(s)
Number of adverse outcomes in relation to Insulin resistance measured as CXCL5 [Time Frame: 30 days after surgery]
Number of adverse outcomes in relation to Insulin resistance measured as QUICKI [Time Frame: 30 days after surgery]
Number of adverse outcomes in relation to Insulin resistance measured as HbA1c [Time Frame: 30 days after surgery]
Number of adverse outcomes in relation to Insulin resistance measured as ANGPTL2 [Time Frame: 30 days after surgery]
Number of adverse outcomes in relation to Insulin resistance measured as irisin [Time Frame: 30 days after surgery]
Number of adverse outcomes in relation to Insulin resistance measured as NAMPT [Time Frame: 30 days after surgery]
Secondary ID(s)
56/13
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
McGill University
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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