High Dose Insulin Therapy to Improve Liver Function
Recruitment status was: Active, not recruiting
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||High Dose Insulin Therapy to Improve Liver Function in Patients With HCV Liver Cirrhosis|
- Liver status improvments (biochemical and histological) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Insulin resistance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Inflammatory mediators [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Experimental: Insulin/dextrose clamp||
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.
Other Name: Hyperinsulinemic normoglycemic clamp
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271140
|McGill University Helath Centre - (Royal Victoria Hospital)|
|Montreal, Quebec, Canada, H3A 1A1|
|Principal Investigator:||Peter Metrakos, MD||McGill University Health Center|