Actively Recruiting
Application of High-Dose Insulin Therapy Using a Hyperinsulinemic Normoglycemic Clamp to Improve Liver Function and Regeneration
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2024-11-20
70
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether high-dose insulin therapy can improve liver function before major liver surgery in patients with colorectal liver metastasis. The trial aims to understand if this therapy enhances liver function pre-operatively, its effects after a liver venous deprivation (LVD) procedure, and the relationship between liver volume growth and function during regeneration. This study is interventional and explores these effects using specialized liver imaging techniques. Participants will receive a 6-hour infusion of insulin and dextrose to maintain a stable blood sugar level before their planned liver surgery. The study has three groups: one receiving insulin therapy before surgery, one receiving insulin therapy after LVD, and one group undergoing LVD without insulin treatment. Insulin dosing is carefully controlled with blood sugar monitoring every 15 minutes during the infusion. During the study, liver function and regeneration will be assessed using 99mTc-Mebrofenin hepatobiliary scintigraphy and CT scans at specific times before and after treatment. Researchers will measure liver function improvements within 24 hours or 7 days post-treatment depending on the group. Participants may be involved in imaging, blood glucose monitoring, and clinical evaluations throughout their participation, which continues until after their liver surgery and follow-up assessments.
CONDITIONS
Brief Title
Application of High-dose Insulin Therapy to Improve Liver Function and Regeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years old
- Candidate for major liver resection
- Resectable colorectal liver metastasis
You will not qualify if you...
- Inability to give consent
- Type 1 diabetes mellitus
- Uncontrolled blood glucose levels (fasting level over 10 mmol/L)
- Unresectable colorectal liver metastasis
- Extrahepatic metastatic disease that is unresectable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 hours
Participants receive high-dose insulin therapy involving an insulin infusion and controlled dextrose administration to maintain blood glucose levels within a target range for 6 hours.
1 treatment visit (in-person)
Duration - Up to 7 days after treatment
Participants undergo assessments of liver function and regeneration after treatment using imaging techniques.
1 to 2 follow-up visits depending on group assignment
Trial Site Locations
Total: 1 location
1
McGill Univeristy Health Centre
Montreal, Quebec, Canada, H3A 1A1
Actively Recruiting
Research Team
J
Jennifer Kalil, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here