Insulin ResistanceNCT02258698
Insulin Sensitivity, Irisin and Adipokines as Outcome Parameters in Patients Undergoing Cardiac Surgery
An observational study of Insulin Resistance and Diabetes Mellitus Type 2, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insulin Resistance, Diabetes Mellitus Type 2, Other Functional Disturbances Following Cardiac Surgery
- What is being tested?
- Cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 348 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2013to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Blood glucose values requiring continuous insulin infusion preoperatively
- Ongoing selenium therapy
- Pregnancy
- Interventional valve repair
- Intraoperative hypothermic cardiac arrest
- Off-pump cardiac surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
see Information below
- Conditions
- Insulin Resistance, Diabetes Mellitus Type 2, Other Functional Disturbances Following Cardiac Surgery
- Being tested
- Cardiac surgery
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeryProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Elective on-pump cardiac surgery | Observation of perioperative Insulin resistance in patients undergoing elective on-pump cardiac surgery (CABG and/or valve repair) Receives: Procedure: Cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse outcomes in relation to Insulin resistance measured as HOMA (homeostasis model assessment)
Measured: 30 days after surgery
Secondary outcomes (6)
Number of adverse outcomes in relation to Insulin resistance measured as QUICKI
Measured: 30 days after surgery
Number of adverse outcomes in relation to Insulin resistance measured as HbA1c
Measured: 30 days after surgery
Number of adverse outcomes in relation to Insulin resistance measured as ANGPTL2
Measured: 30 days after surgery
Number of adverse outcomes in relation to Insulin resistance measured as CXCL5
Measured: 30 days after surgery
Number of adverse outcomes in relation to Insulin resistance measured as NAMPT
Measured: 30 days after surgery
Number of adverse outcomes in relation to Insulin resistance measured as irisin
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startMay 2013
- Primary completionMay 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University
- Responsible party
- Sponsor
- Investigators
- Andrea Kopp Lugli, MD, MSc, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258698
- Sponsor's protocol ID
- 56/13
- Status last verified
- Jan 2017
- First submitted
- 29 Sep 2014
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Sensitivity, Irisin and Adipokines as Outcome Parameters in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02258698
- Acronym / sponsor ID
- 56/13
- Conditions
- Insulin Resistance, Diabetes Mellitus Type 2, Other Functional Disturbances Following Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- McGill University
- Study start
- May 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective on-pump cardiac surgery | – | Procedure: Cardiac surgeryObservation of perioperative Insulin resistance in patients undergoing elective on-pump cardiac surgery (CABG and/or valve repair) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Blood glucose values requiring continuous insulin infusion preoperatively
- Ongoing selenium therapy
- Pregnancy
- Interventional valve repair
- Intraoperative hypothermic cardiac arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac surgeryBlood 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. | Procedure or surgery | Elective on-pump cardiac surgery |
Primary outcome
Number of adverse outcomes in relation to Insulin resistance measured as HOMA (homeostasis model assessment)
Time frame: 30 days after surgery
6 secondary outcomes
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 CXCL5
Time frame: 30 days after surgery
Number of adverse outcomes in relation to Insulin resistance measured as NAMPT
Time frame: 30 days after surgery
Number of adverse outcomes in relation to Insulin resistance measured as irisin
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Kopp Lugli, MD, MSc principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance and Diabetes Mellitus Type 2, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse outcomes in relation to Insulin resistance measured as HOMA (homeostasis model assessment) (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.