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

Liver Metastasis Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06126419
• Other study ID #: 2023-8880
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2023
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Diseases
• Liver Dysfunction
• Liver Metastasis Colon Cancer
• Liver Regeneration
• Neoplasm Metastasis

Intervention

Drug:
• High-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

Country	Name	City	State
Canada	McGill Univeristy Health Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver function improvement after high-dose insulin therapy measured with 99mTc-Mebrofenin Hepatobiliary Scintigraphy (HBS).	99mTc-Mebrofenin HBS is a diagnostic nuclear medicine imaging procedure used to evaluate liver function by measuring radiotracer uptake and excretion. The outcome will be evaluating a measurable increase in 99mTc-Mebrofenin (measured %/min/meter^2) from baseline scan to post-treatment scan.	Baseline to 24-hours post treatment
Primary	Liver function improvement after high-dose insulin therapy after LVD measured with 99mTc-Mebrofenin Hepatobiliary Scintigraphy (HBS).	99mTc-Mebrofenin HBS is a diagnostic nuclear medicine imaging procedure used to evaluate liver function by measuring radiotracer uptake and excretion. The outcome will be evaluating a measurable increase in 99mTc-Mebrofenin (measured %/min/meter^2) from baseline scan to post-treatment scan.	Baseline to 7 days post treatment
Primary	Liver regeneration improvement after high-dose insulin therapy after LVD measured CT volumetry	The volume of the liver can be measured from liver protocoled CT scans	Baseline to 7 days post treatment