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

November 28, 2023 updated by: peter metrakos, McGill University Health Centre/Research Institute of the McGill University Health Centre

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Recruiting
        • McGill Univeristy Health Centre
        • Contact:
        • Principal Investigator:
          • Dr. Peter Metrakos, MD, Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

November 6, 2023

First Submitted That Met QC Criteria

November 6, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-8880

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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