High Dose Insulin Therapy to Improve Liver Function

Hepatitis C Virus Clinical Trial

Official title:

High Dose Insulin Therapy to Improve Liver Function in Patients With HCV Liver Cirrhosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01271140
• Other study ID #: 10-086-BMA
• Status: Active, not recruiting
• Phase: N/A
• First received: January 5, 2011
• Last updated: November 11, 2013
• Start date: January 2011
• Est. completion date: June 2014

Study information

• Verified date: November 2013
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada : Mcgill University Health Centre
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C Virus

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Canada	McGill University Helath Centre - (Royal Victoria Hospital)	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver status improvments (biochemical and histological)		6 months	No
Secondary	Insulin resistance		6 months	No
Secondary	Inflammatory mediators		6 months	No