Application of High-Dose Insulin Therapy Using a Hyperinsulinemic Normoglycemic Clamp to Improve Liver Function and Regeneration

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \> 18 years old

• Candidate for major liver resection

• Resectable colorectal liver metastasis

Locations
Other Locations
Canada
McGill Univeristy Health Centre
RECRUITING
Montreal
Contact Information
Primary
Jennifer Kalil, MD
jennifer.kalil@mail.mcgill.ca
514-934-1934
Time Frame
Start Date: 2023-11-08
Estimated Completion Date: 2026-12
Participants
Target number of participants: 70
Treatments
Experimental: Group 1: Effect of high-dose insulin therapy on pre-operative liver function
Group 1 will consist of participants scheduled for liver resection and will undergo high-dose insulin pre-operatively to determine if baseline liver function can be optimized/improved, as measured by 99mTc-Mebrofenin HBS.
Experimental: Group 2: Effect of high-dose insulin therapy on pre-operative liver function after LVD
Group 2 will consist of participants scheduled for liver resection that require LVD. The participants in the experimental arm will receive high-dose insulin therapy after LVD.
No_intervention: Group 3: Effect of high-dose insulin therapy on pre-operative liver function after LVD
Group 3 will consist of participants scheduled for liver resection that require LVD. The participants in the no intervention arm will not undergo intervention with high-dose insulin therapy after LVD.
Sponsors
Leads: McGill University Health Centre/Research Institute of the McGill University Health Centre

This content was sourced from clinicaltrials.gov

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