RecruitingNot ApplicableNCT06126419

Application of High-dose Insulin Therapy to Improve Liver Function and Regeneration

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


Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrollment

70 participants

Start Date

Nov 8, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • Age \> 18 years old
  • Candidate for major liver resection
  • Resectable colorectal liver metastasis

Exclusion Criteria5

  • 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

Interventions

DRUGHigh-Dose Insulin Therapy

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.


Locations(1)

McGill Univeristy Health Centre

Montreal, Quebec, Canada

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NCT06126419


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