Using high-dose insulin therapy to enhance liver function before surgery
Application of High-Dose Insulin Therapy Using a Hyperinsulinemic Normoglycemic Clamp to Improve Liver Function and Regeneration
NA · McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT06126419
This study is testing if high-dose insulin therapy can help improve liver function in patients who are about to have major liver surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre (other) |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06126419 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to determine whether high-dose insulin therapy can improve liver function in patients scheduled for major liver surgery. Participants will undergo a 6-hour infusion of insulin and dextrose to maintain a hyperinsulinemic-normoglycemic state in the weeks leading up to their surgery. The study will assess the effects of this therapy on liver function and regeneration, particularly after a liver venous deprivation procedure, using 99m-Tc-Mebrofenin hepatobiliary scintigraphy. The research seeks to optimize the future liver remnant for better surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are scheduled for major liver resection due to resectable colorectal liver metastasis.
Not a fit: Patients with uncontrolled blood glucose levels, type 1 diabetes, or unresectable metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance liver function and regeneration in patients undergoing liver surgery, potentially improving surgical outcomes.
How similar studies have performed: While the specific application of high-dose insulin therapy in this context may be novel, similar approaches in enhancing liver function have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montreal, Quebec
- McGill Univeristy Health Centre — Montreal, Quebec, Canada (RECRUITING)
Study contacts
- Study coordinator: Jennifer Kalil, MD
- Email: jennifer.kalil@mail.mcgill.ca
- Phone: 514-934-1934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liver Dysfunction, Liver Metastasis Colon Cancer, Liver Regeneration, Hyperinsulinemic-Normoglycemic Clamp, High Dose Insulin Therapy, 99mTc-Mebrofenin Hepatobiliary Scintigraphy, Colorectal Cancer Liver Metastasis, Liver Resection