Clinical trial NCT06126419: Application of High-dose Insulin Therapy to Improve Liver Function and Regeneration
Official title: Application of High-Dose Insulin Therapy Using a Hyperinsulinemic Normoglycemic Clamp to Improve Liver Function and Regeneration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Dysfunction
Liver Metastasis Colon Cancer
Liver Regeneration
Keywords: Hyperinsulinemic-Normoglycemic Clamp
High Dose Insulin Therapy
99mTc-Mebrofenin Hepatobiliary Scintigraphy
Colorectal Cancer Liver Metastasis
Liver Resection
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.


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

Primary outcomes:
measure: Liver function improvement after high-dose insulin therapy measured with 99mTc-Mebrofenin Hepatobiliary Scintigraphy (HBS).
timeFrame: Baseline to 24-hours post treatment
measure: Liver function improvement after high-dose insulin therapy after LVD measured with 99mTc-Mebrofenin Hepatobiliary Scintigraphy (HBS).
timeFrame: Baseline to 7 days post treatment
measure: Liver regeneration improvement after high-dose insulin therapy after LVD measured CT volumetry
timeFrame: Baseline to 7 days post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill Univeristy Health Centre
state: Quebec
Study officials:
References: