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

Liver Metastasis Colon Cancer Liver Dysfunction Liver Regeneration

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

Plain Language Summary

Simplified for easier understanding

This trial is studying whether giving high-dose insulin therapy before a major liver surgery can help protect liver function and improve the liver's ability to regenerate afterward, in patients with colorectal cancer that has spread to the liver. **You may be eligible if:** - You are over 18 years old - You have colorectal cancer that has spread to the liver (colorectal liver metastasis) - Your liver tumors are considered surgically removable - You are scheduled for a major liver resection (removal of part of the liver) **You may NOT be eligible if:** - You cannot give informed consent - You have type 1 diabetes - Your blood sugar is poorly controlled (fasting level above 10 mmol/L) - Your liver tumors cannot be surgically removed - You have cancer that has spread beyond the liver that cannot be removed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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