High Dose Insulin Therapy to Improve Liver Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01271140
Recruitment Status : Unknown
Verified November 2013 by peter metrakos, McGill University Health Center.
Recruitment status was:  Active, not recruiting
First Posted : January 6, 2011
Last Update Posted : November 13, 2013
Information provided by (Responsible Party):
peter metrakos, McGill University Health Center

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Drug: Insulin Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose Insulin Therapy to Improve Liver Function in Patients With HCV Liver Cirrhosis
Study Start Date : January 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Insulin/dextrose clamp 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.
Other Name: Hyperinsulinemic normoglycemic clamp

Primary Outcome Measures :
  1. Liver status improvments (biochemical and histological) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Insulin resistance [ Time Frame: 6 months ]
  2. Inflammatory mediators [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01271140

Canada, Quebec
McGill University Helath Centre - (Royal Victoria Hospital)
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
McGill University Health Center
Principal Investigator: Peter Metrakos, MD McGill University Health Center

Responsible Party: peter metrakos, Director Multiorgan Transplant Program-MUHC, McGill University Health Center Identifier: NCT01271140     History of Changes
Other Study ID Numbers: 10-086-BMA
First Posted: January 6, 2011    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs