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

Not Applicable

Recruiting

• Conditions: Liver Regeneration; Liver Dysfunction; Liver Metastasis Colon Cancer
• Interventions: Drug: High-Dose Insulin Therapy

• Registration Number: NCT06126419
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-06
• Study Start: 2023-11-08
• Study First Posted: 2023-11-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2026-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Effect of high-dose insulin therapy on pre-operative liver function after LVD	High-Dose Insulin Therapy	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 1: Effect of high-dose insulin therapy on pre-operative liver function	High-Dose Insulin Therapy	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.

Primary Outcome Measures

Name	Time	Method
Liver function improvement after high-dose insulin therapy measured with 99mTc-Mebrofenin Hepatobiliary Scintigraphy (HBS).	Baseline to 24-hours post treatment	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.
Liver function improvement after high-dose insulin therapy after LVD measured with 99mTc-Mebrofenin Hepatobiliary Scintigraphy (HBS).	Baseline to 7 days post treatment	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.
Liver regeneration improvement after high-dose insulin therapy after LVD measured CT volumetry	Baseline to 7 days post treatment	The volume of the liver can be measured from liver protocoled CT scans

Trial Locations

Locations (1)

McGill Univeristy Health Centre; 🇨🇦 Montreal, Quebec, Canada