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Trial Title:
Application of High-dose Insulin Therapy to Improve Liver Function and Regeneration
NCT ID:
NCT06126419
Condition:
Liver Dysfunction
Liver Metastasis Colon Cancer
Liver Regeneration
Conditions: Official terms:
Neoplasm Metastasis
Liver Diseases
Insulin
Conditions: Keywords:
Hyperinsulinemic-Normoglycemic Clamp
High Dose Insulin Therapy
99mTc-Mebrofenin Hepatobiliary Scintigraphy
Colorectal Cancer Liver Metastasis
Liver Resection
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Group 1 will consist of participants scheduled for liver resection and will undergo
high-dose insulin therapy preoperatively to determine if baseline liver function can be
optimized/improved, as measured by 99mTc-Mebrofenin HBS. Cytokine profiling will also be
collected and analyzed pre- and post-insulin infusion.
Group 2 will consist of participants scheduled for liver resection that require LVD. They
will then be randomized to two different arms -- control vs high-dose insulin therapy.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
High-Dose Insulin Therapy
Description:
A baseline blood glucose value will be obtained. Two units of insulin will be
administered IV if the blood glucose is > mmol/L. An insulin infusion of 0.12 units/kg/hr
will be started. Ten minutes after starting the insulin, and when the blood glucose is <
6 mmol/L, dextrose 20% supplemented with phosphate (30 mmol/L) will be infused. Blood
glucose levels will be measured every 15 minutes, and the dextrose infusion rate adjusted
to maintain glycemic levels between 4 and 6 mmol/L for a duration of 6 hours. At the end
of the 6 hour period, the insulin will be stopped and the dextrose will be weaned off.
Arm group label:
Group 1: Effect of high-dose insulin therapy on pre-operative liver function
Arm group label:
Group 2: Effect of high-dose insulin therapy on pre-operative liver function after LVD
Summary:
The primary objective of this interventional study is determine if the future liver
remnant can be optimized by improving liver function pre-operatively in patients who are
scheduled for major hepatectomy. The main questions it aims to answer are:
1. Does high-dose insulin therapy improve liver function in the pre-operative setting?
2. What is the effect of high-dose insulin therapy on liver function and liver
regeneration after a liver venous deprivation (LVD) procedure?
3. What is the relationship between volume hypertrophy and function in the regenerating
liver? Participants will receive a 6-hour infusion of insulin and dextrose to
maintain a hyperinsulinemic-normoglycemic state in the weeks prior to planned liver
surgery to assess its effect on liver function measured by 99m-Tc-Mebrofenin
hepatobiliary scintigraphy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age > 18 years old
- Candidate for major liver resection
- Resectable colorectal liver metastasis
Exclusion Criteria:
- Inability to give consent
- Type 1 diabetes mellitus
- Uncontrolled blood glucose levels (fasting level > 10 mmol/L)
- Unresectable colorectal liver metastasis
- Extrahepatic metastatic disease that is unresectable
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
McGill Univeristy Health Centre
Address:
City:
Montreal
Zip:
H3A 1A1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Jennifer Kalil, MD
Phone:
5148396682
Email:
jennifer.kalil@mail.mcgill.ca
Investigator:
Last name:
Dr. Peter Metrakos, MD, Surgery
Email:
Principal Investigator
Start date:
November 8, 2023
Completion date:
July 2025
Lead sponsor:
Agency:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Agency class:
Other
Source:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06126419
