Application of High-dose Insulin Therapy to Improve Liver Function and Regeneration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-Dose Insulin Therapy.
- Who it may be relevant to
- Registry conditions: Liver Dysfunction, Liver Metastasis Colon Cancer, Liver Regeneration. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Application of High-Dose Insulin Therapy Using a Hyperinsulinemic Normoglycemic Clamp to Improve Liver Function and Regeneration
Overview
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.
Interventions
- Drug High-Dose Insulin Therapy
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
Primary outcome measures
- Liver function improvement after high-dose insulin therapy measured with 99mTc-Mebrofenin Hepatobiliary Scintigraphy (HBS). [Time frame: Baseline to 24-hours post treatment]
- 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]
- Liver regeneration improvement after high-dose insulin therapy after LVD measured CT volumetry [Time frame: Baseline to 7 days post treatment]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- McGill Univeristy Health Centre — Montreal
Identifiers
NCT: NCT06126419 · 2023-8880