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

McGill University

Status: Enrolling

Conditions: Liver Metastasis Colon Cancer; Liver Regeneration; Liver Dysfunction

Treatments: Drug: High-Dose Insulin Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06126419

2023-8880

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 3 patient groups

Group 1: Effect of high-dose insulin therapy on pre-operative liver function

Experimental group

Description:

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.

Treatment:

Drug: High-Dose Insulin Therapy

Group 2: Effect of high-dose insulin therapy on pre-operative liver function after LVD

Experimental group

Description:

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.

Treatment:

Drug: High-Dose Insulin Therapy

Group 3: Effect of high-dose insulin therapy on pre-operative liver function after LVD

No Intervention group

Description:

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.