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

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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)

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.

Trial contacts and locations

1

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Central trial contact

Jennifer Kalil, MD

Data sourced from clinicaltrials.gov

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