Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000278639
Ethics application status
Approved
Date submitted
22/02/2014
Date registered
17/03/2014
Date last updated
22/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes in postoperative insulin resistance in liver surgery if the patients keep normal blood glucose
Scientific title
Differences in hepatic and peripheral postoperative insulin resistance in patients under glucose control during liver surgery
Secondary ID [1] 284037 0
Nil
Universal Trial Number (UTN)
U1111-1152-9738
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative insulin resistance 291091 0
Condition category
Condition code
Metabolic and Endocrine 291433 291433 0 0
Diabetes
Surgery 291434 291434 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this randomized prospective study, 20 evaluable patients scheduled for hepatic resection at a university hospital, will be included. The treatment group receives continuous insulin infusion (1 U/ml) to obtain near normoglycemia (n=10)at the start of anesthesia, the control group receive intermittent insulin when needed (B-glu greater than 200 mg/l). The insulin infusion is stopped at the end of the surgery. A pre- and postoperative hyperinsulinemic normoglycemic clamp with isoptope tracer infusion will be performed in addition with tissue samples from muscle and liver to evulate postoperative insulin resistance.
Intervention code [1] 288729 0
Prevention
Comparator / control treatment
Continuous intravenous insulin infusion to receive near normoglycemia is compared to the standard treatment (i.e. intermittent intravenous infusion if B-glu>200 g/l)
Control group
Active

Outcomes
Primary outcome [1] 291419 0
To measure the effect of peroperative insulin infusion on glucose utilization and production using isotope tracer infusion.
Timepoint [1] 291419 0
1 hour after surgery, in the postoperative ward
Primary outcome [2] 291545 0
To measure the difference in % of postoperative insulin resistance (glucose mg/kg/min) compared to preoperative values.
Timepoint [2] 291545 0
1 hour after surgery, in the postoperative ward
Secondary outcome [1] 306728 0
To measure the effect of peroperative insulin infusion on changes in hormone levels during surgery (plasma levels of C-peptide, insulin and cortisol).
Timepoint [1] 306728 0
During surgery and after the hyperinsulinemic normoglycemic clamp is completed, in the postoperative ward.
Secondary outcome [2] 306751 0
To measure metabolic changes during surgery in hepatic and muscular tissues samples
Timepoint [2] 306751 0
During surgery, before and after hepatic resection

Eligibility
Key inclusion criteria
Patient scheduled for open hepatectomy, BMI 20-28, informed consent, no contra-indication for epidural analgesia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Preoperative cortison-treatment, diabetes mellitus, severe hepatic or renal failure, contra-indication for pre-operative beverage,


Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using staff not involved in study choose an envelope
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Previous similar study using same number of patients showed significant reduction of insulin resistance during surgery. 2 group powertest with difference between groups of 24,9%, SD 15,5 and 16,2% respectively, with p<0,05 and a power of 80% gives a group size of 6 patients. Normality assessed using Kolmogorov-Smirnov test.
Data normality distribution are given as means+/- SD. Non-parametric data values are given as median (IQR). When applicable Students t-test ,ANOVA, Wilcoxon or Kruskal-Wallis tests will be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/03/2014
Actual
26/03/2014
Date of last participant enrolment
Anticipated
18/12/2015
Actual
10/12/2015
Date of last data collection
Anticipated
Actual
15/12/2015
Sample size
Target
20
Accrual to date
Final
22
Recruitment outside Australia
Country [1] 5807 0
Sweden
State/province [1] 5807 0
Stockholm

Funding & Sponsors
Funding source category [1] 288675 0
Government body
Name [1] 288675 0
The County Counsil of Stockholm (projects 502033)
Country [1] 288675 0
Sweden
Primary sponsor type
Individual
Name
Olav Rooyackers
Address
Dept of Anestesia and Intensive Care
Dept of Clinical Science, Intevention and technology, CLINTEC
Karolinska University Hospital, Hudddinge
141 86 Stockholm
Country
Sweden
Secondary sponsor category [1] 287404 0
None
Name [1] 287404 0
Address [1] 287404 0
Country [1] 287404 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290521 0
Regional Ethical Review Boards, Stockholm
Ethics committee address [1] 290521 0
Nobels vag 9, plan D3
171 65 Solna
Ethics committee country [1] 290521 0
Sweden
Date submitted for ethics approval [1] 290521 0
Approval date [1] 290521 0
05/09/2012
Ethics approval number [1] 290521 0
2012/1324-31/3

Summary
Brief summary
Surgery induces a form of diabetes, characterized by elevated blood glucose as a result of insulin resistance. A high glucose is a risk for postoperative infections and cardiovascular events. A normalisation of blood glucose improves both morbidity and mortality. This has been demonstrated in critically ill patients and during operation, especially in cardiovascular surgery. Insulin resistance can be modulated for example by the size of surgery, normalisation of glucose and adequate pain management. The changes observed in deprived insulin sensitivity can derive from the liver where glucose is produced or from peripheral tissues where glucose is metabolised. To understand the metabolic changes during operation insulin resistance is measured, and to discriminate the localisation of insulin resistance, a tracer infusion is used in addition to a hyperinsulinemic normoglycemic clamp. In this randomized prospective study patients scheduled for liver resection are treated to near normoglycemia using insulin infusion or standard treatment with intermittent insulin and differences between the groups in insulin resistance are measured.
Trial website
icu-metabolism.se
Trial related presentations / publications
Not applicable,
Public notes

Contacts
Principal investigator
Name 46046 0
Prof Olav Rooyackers
Address 46046 0
Dept of Anesthesiology and Intensive Care
Karolinska University Hospital, Huddinge
141 86 Stockholm
Country 46046 0
Sweden
Phone 46046 0
+46 8 58 58 00 00
Fax 46046 0
Email 46046 0
[email protected]
Contact person for public queries
Name 46047 0
Dr Christina Blixt
Address 46047 0
Dept of Anesthesiology and Intensive Care
Karolinska University Hospital, Huddinge
141 86 Stockholm
Country 46047 0
Sweden
Phone 46047 0
+46 8 58 58 00 00
Fax 46047 0
Email 46047 0
[email protected]
Contact person for scientific queries
Name 46048 0
Dr Christina Blixt
Address 46048 0
Dept of Anesthesiology and Intensive Care
Karolinska University Hospital, Huddinge
141 86 Stockholm
Country 46048 0
Sweden
Phone 46048 0
+46 8 58 58 00 00
Fax 46048 0
Email 46048 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of glucose control in liver surgery on glucose kinetics and insulin resistance.2021https://dx.doi.org/10.1016/j.clnu.2021.05.017
N.B. These documents automatically identified may not have been verified by the study sponsor.