Recruiting

High-dose Insulin

Sponsor:

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

Code:

NCT06126419

Conditions

Liver Dysfunction

Liver Metastasis Colon Cancer

Liver Regeneration

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High-Dose Insulin Therapy

Study Details

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 ID

NCT06126419

Start date

Nov 8, 2023

Status verified date

Nov, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

no intervention: 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.

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.

Primary outcome measure

  • Liver function improvement after high-dose insulin therapy measured with 99mTc-Mebrofenin Hepatobiliary Scintigraphy (HBS). [ Time Frame: Baseline to 24-hours post treatment ]
  • Liver function improvement after high-dose insulin therapy after LVD measured with 99mTc-Mebrofenin Hepatobiliary Scintigraphy (HBS). [ Time Frame: Baseline to 7 days post treatment ]
  • Liver regeneration improvement after high-dose insulin therapy after LVD measured CT volumetry [ Time Frame: Baseline to 7 days post treatment ]

Central Contacts and Locations

Central contacts

Jennifer Kalil, MD

514-934-1934jennifer.kalil@mail.mcgill.ca

Locations

McGill Univeristy Health Centre

Recruiting

Montreal, Quebec, Canada, H3A 1A1

Contacts

Jennifer Kalil, MD

514-934-1934jennifer.kalil@mail.mcgill.ca

Principal Investigator:

Dr. Peter Metrakos, MD, Surgery

More Information

Sponsor

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

Last update posted

Nov 20, 2024

Last verified

Nov, 2024

Keywords

  • Hyperinsulinemic-Normoglycemic Clamp
  • High Dose Insulin Therapy
  • 99mTc-Mebrofenin Hepatobiliary Scintigraphy
  • Colorectal Cancer Liver Metastasis
  • Liver Resection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2024-11-20.