Tests high-dose insulin to help the liver before major liver surgery
Tests high-dose insulin infusion in adults before planned major liver surgery.
Key facts
- Who runs it
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Where
- Montreal, CanadaSee the site
- Trial code
- Registry title
- Application of High-dose Insulin Therapy to Improve Liver Function and Regeneration
- Status
- Recruiting
- People taking part
- 70 people, planned
- Started
- 8 Nov 2023
- Expected to end
- Dec 2026
- Type of study
- Interventional, 3 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- High-Dose Insulin Therapy
- Record updated
- 20 November 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who are planned for a major liver operation because of colorectal cancer that has spread to the liver and can be removed by surgery.
- Age
- Older than 18 years (minimum age 18 years).
- Sex
- All sexes can join.
- Disease stage
- Colorectal cancer that has spread to the liver and can be removed by surgery. The person is a candidate for major liver resection.
Main reasons for not taking part
- Cannot give consent
- Type 1 diabetes
- Uncontrolled blood sugar (fasting level above 10 mmol/L (180 mg/dL))
- Colorectal liver metastasis that cannot be removed by surgery
- Cancer outside the liver that cannot be removed by surgery
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Age > 18 years old
- Candidate for major liver resection
- Resectable colorectal liver metastasis
Who cannot take part
- Type 1 diabetes mellitus
- Extrahepatic metastatic disease that is unresectable
- Uncontrolled blood glucose levels (fasting level > 10 mmol/L)
- Inability to give consent
- Unresectable colorectal liver metastasis
Where in Canada
- McGill Univeristy Health CentreMontreal, CanadaContact: Jennifer Kalil, MDTaking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
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.
The 3 groups in the trial
- Group 1: Effect of high-dose insulin therapy on pre-operative liver functionTreatment being tested
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: High-Dose Insulin Therapy
- Group 2: Effect of high-dose insulin therapy on pre-operative liver function after LVDTreatment being tested
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: High-Dose Insulin Therapy
- Group 3: Effect of high-dose insulin therapy on pre-operative liver function after LVDNo study treatment, for comparison
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Application of High-Dose Insulin Therapy Using a Hyperinsulinemic Normoglycemic Clamp to Improve Liver Function and Regeneration
- Plain-language title
- Tests high-dose insulin to help the liver before major liver surgeryGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 20 November 2024