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Hormone Therapy

High-Dose Insulin Therapy for Liver Regeneration

N/A

Recruiting

Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years old

Candidate for major liver resection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 24-hours post treatment

Awards & highlights

Study Summary

This trial seeks to find out if a high-dose insulin infusion before major liver surgery can improve liver function and regeneration.

Who is the study for?

This trial is for adults over 18 who are set to undergo major liver surgery due to resectable colorectal liver metastasis. It's exploring whether high-dose insulin therapy can help improve the liver's function and its ability to regenerate before the operation.Check my eligibility

What is being tested?

The study tests if a pre-surgery treatment involving a 6-hour infusion of insulin and dextrose, which keeps blood sugar normal but raises insulin levels, can enhance how well the liver works and regrows after part of it is removed (hepatectomy).See study design

What are the potential side effects?

Potential side effects may include low blood sugar levels due to high doses of insulin, possible electrolyte imbalances, or reactions at the infusion site. Close monitoring during therapy aims to minimize risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I am a candidate for major surgery to remove part of my liver.

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My liver cancer from colorectal origin can be surgically removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24-hours post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24-hours post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24-hours post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Liver function improvement after high-dose insulin therapy after LVD measured with 99mTc-Mebrofenin Hepatobiliary Scintigraphy (HBS).

Liver function improvement after high-dose insulin therapy measured with 99mTc-Mebrofenin Hepatobiliary Scintigraphy (HBS).

Liver regeneration improvement after high-dose insulin therapy after LVD measured CT volumetry

Side effects data

From 2016 Phase 4 trial • 85 Patients • NCT01970241

21%

Hypoglycemia

100%

80%

60%

40%

20%

Study treatment Arm

NPH With Corticosteroid

Control

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Group 2: Effect of high-dose insulin therapy on pre-operative liver function after LVDExperimental Treatment1 Intervention

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.

Group II: Group 1: Effect of high-dose insulin therapy on pre-operative liver functionExperimental Treatment1 Intervention

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.

Group III: Group 3: Effect of high-dose insulin therapy on pre-operative liver function after LVDActive Control1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor

447 Previous Clinical Trials

159,682 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots left in this research endeavor for participants?

"Affirmative. The clinical trial registration on clinicaltrials.gov verifies that the research, which was first publicized on November 8th 2023, is currently recruiting participants. 70 patients are required to be enrolled from one medical centre."

Answered by AI

What is the current enrollment for this medical investigation?

"Affirmative. As per the clinicaltrials.gov records, this study is proactively recruiting participants. It was initially published on November 8th 2023 and modified most recently on November 28th of the same year. 70 individuals are expected to be admitted at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Application of High-dose Insulin Therapy to Improve Liver Function and Regeneration

peter metrakos 2023. "Application of High-dose Insulin Therapy to Improve Liver Function and Regeneration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06126419.