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Clinical trial

Application of High-Dose Insulin Therapy Using a Hyperinsulinemic Normoglycemic Clamp to Improve Liver Function and Regeneration

ID
Name
2023-8880
Description
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.
Trial arms
Trial start
2023-11-08
Estimated PCD
2025-01-01
Trial end
2025-07-01
Status
Recruiting
Treatment
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 of 6 hours. At the end of the 6 hour period, the insulin will be stopped and the dextrose will be weaned off.
Arms:
Group 1: Effect of high-dose insulin therapy on pre-operative liver function, Group 2: Effect of high-dose insulin therapy on pre-operative liver function after LVD
Size
70
Primary endpoint
Liver function improvement after high-dose insulin therapy measured with 99mTc-Mebrofenin Hepatobiliary Scintigraphy (HBS).
Baseline to 24-hours post treatment
Liver function improvement after high-dose insulin therapy after LVD measured with 99mTc-Mebrofenin Hepatobiliary Scintigraphy (HBS).
Baseline to 7 days post treatment
Liver regeneration improvement after high-dose insulin therapy after LVD measured CT volumetry
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group 1 will consist of participants scheduled for liver resection and will undergo high-dose insulin therapy preoperatively to determine if baseline liver function can be optimized/improved, as measured by 99mTc-Mebrofenin HBS. Cytokine profiling will also be collected and analyzed pre- and post-insulin infusion.\n\nGroup 2 will consist of participants scheduled for liver resection that require LVD. They will then be randomized to two different arms -- control vs high-dose insulin therapy.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}
Updated at
2023-12-04

1 organization

1 product

3 indications

Organization
McGill University Health Centre
Product
High-Dose Insulin
Indication
Liver Dysfunction
Indication
Liver Metastasis Colon Cancer
Indication
Liver Regeneration