Hepatitis C Virus
Conditions
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.
Interventions
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.
Sponsors
Study design
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver status improvments (biochemical and histological) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Insulin resistance | 6 months |
| Inflammatory mediators | 6 months |
Countries
Canada