High Dose Insulin Therapy to Improve Liver Function

NCT ID: NCT01271140

Last Updated: 2013-11-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-06-30

Brief Summary

Insulin resistance is one of the key factors in defining a progressive course of chronic Hepatitis C virus (HCV) infection and hepatic fibrosis. Multiple trials have targeted insulin resistance as an adjuvant way to manage hepatitis C liver disease with promising results.

Long term therapy using high dose insulin was shown to significantly reduce insulin resistance in obese patients. In cardiac and critically ill patients, long term insulin was shown to produce better outcomes mainly by reducing the overt inflammatory response. Furthermore, initial results of ongoing trials are revealing more benefits of insulin therapy. Using the (hyperinsulinimic normoglycemic clamp) for eight hours on patients undergoing major liver resection was able to maximize their liver function post-operatively. This trial also demonstrated inhibition of the inflammatory response, improvement in liver glycogen, inhibition of apoptosis and stimulation of liver regeneration.

Putting in mind the potential ability of the liver to regenerate and regain better function. The anti-inflammatory properties of insulin therapy along with its ability to reduce insulin resistance over time has led us to see the potential benefits of using insulin therapy on patients with chronic hepatitis C virus liver cirrhosis. Insulin will target the pathophysiology of the disease at a cellular and a molecular level.

The investigators theorize that long-term high insulin therapy would be able to promote better liver function and slow down fibrosis and injury in this population of patients.

Conditions

Hepatitis C Virus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin/dextrose clamp

Group Type: EXPERIMENTAL

Insulin

Intervention Type: DRUG

Intravenous insulin clamp at a rate of 2 mlu/kg/hr. In adition a titrating dose of 20% dextrose aiming to a blood glucose level of 4 - 5.5 mmol/l.

Interventions

Insulin

Intravenous insulin clamp at a rate of 2 mlu/kg/hr. In adition a titrating dose of 20% dextrose aiming to a blood glucose level of 4 - 5.5 mmol/l.

Intervention Type: DRUG

Other Intervention Names

Hyperinsulinemic normoglycemic clamp

Eligibility Criteria

Inclusion Criteria

• Hepatitis C positive adult patients (serum HCV antibody positive)
• MELD score 6-15 at the time of inclusion
• Viral genotype "non-3"
• Not on antiviral therapy

Exclusion Criteria

• HBV or HIV co-infection
• Evidence of hepatocellular carcinoma at the start of the trial either by imaging and or AFP levels above 400
• Undetectable HCV viral load (using HCV PCR test)
• Recent infection or bleeding (in the last 3 months)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

peter metrakos

Director Multiorgan Transplant Program-MUHC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Metrakos, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

McGill University Helath Centre - (Royal Victoria Hospital)

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

10-086-BMA

Identifier Type: -

Identifier Source: org_study_id