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NCT Number: NCT06126419

Application of High-dose Insulin Therapy 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.

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Key information

Conditions

Liver Dysfunction Digestive System Diseases Liver Diseases Liver Metastasis Colon Cancer Liver Regeneration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill Univeristy Health Centre

Montreal, Quebec, H3A 1A1, Canada

Location status: Recruiting

Location contact

Dr. Peter Metrakos, MD, Surgery

PRINCIPAL_INVESTIGATOR

Jennifer Kalil, MD

CONTACT

[email protected]

514-934-1934 ext. 76150

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-Dose Insulin Therapy

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Kalil, MD

CONTACT

[email protected]

514-934-1934 ext. 65657

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2023
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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