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

NCT ID: NCT06126419

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-08
• Study Completion Date: 2026-12-31

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.

Conditions

Liver Dysfunction; Liver Metastasis Colon Cancer; Liver Regeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

High-Dose Insulin Therapy

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

High-Dose Insulin Therapy

Intervention Type: DRUG

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

peter metrakos

Professor of Surgery, Program Leader - MUHC-RI Cancer Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

McGill Univeristy Health Centre

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jennifer Kalil, MD

Role: CONTACT

jennifer.kalil@mail.mcgill.ca

514-934-1934 ext. 65657

Facility Contacts

Jennifer Kalil, MD

Role: primary

jennifer.kalil@mail.mcgill.ca

514-934-1934 ext. 76150

Other Identifiers

2023-8880

Identifier Type: -

Identifier Source: org_study_id